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A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03823300
Recruitment Status : Completed
First Posted : January 30, 2019
Results First Posted : May 4, 2022
Last Update Posted : May 4, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Wet Macular Degeneration
Interventions Drug: Faricimab
Drug: Aflibercept
Procedure: Sham Procedure
Enrollment 658
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept
Hide Arm/Group Description Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W). Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
Period Title: Overall Study
Started [1] 331 327
Received at Least One Dose of Study Drug [2] 331 326
Completed up to Week 48 [3] 321 309
Completed 0 0
Not Completed 331 327
Reason Not Completed
Withdrawal by Subject             5             8
Death             2             5
Adverse Event             2             0
Physician Decision             0             2
Protocol Violation             1             1
Lost to Follow-up             0             1
Not Eligible             0             1
Ongoing in the study at Primary Completion Date             321             309
[1]
Intent-to-Treat (ITT) Population
[2]
Safety Population
[3]
Primary Completion Date Cutoff
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept Total
Hide Arm/Group Description Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W). Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104). Total of all reporting groups
Overall Number of Baseline Participants 331 327 658
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 331 participants 327 participants 658 participants
74.8  (8.4) 76.1  (8.6) 75.5  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 331 participants 327 participants 658 participants
Female
203
  61.3%
188
  57.5%
391
  59.4%
Male
128
  38.7%
139
  42.5%
267
  40.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 331 participants 327 participants 658 participants
Hispanic or Latino
35
  10.6%
46
  14.1%
81
  12.3%
Not Hispanic or Latino
287
  86.7%
274
  83.8%
561
  85.3%
Unknown or Not Reported
9
   2.7%
7
   2.1%
16
   2.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 331 participants 327 participants 658 participants
White
278
  84.0%
270
  82.6%
548
  83.3%
Asian
38
  11.5%
34
  10.4%
72
  10.9%
Unknown
12
   3.6%
17
   5.2%
29
   4.4%
Black or African American
2
   0.6%
5
   1.5%
7
   1.1%
American Indian or Alaska Native
1
   0.3%
0
   0.0%
1
   0.2%
Multiple
0
   0.0%
1
   0.3%
1
   0.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 331 participants 327 participants 658 participants
United States and Canada
135
  40.8%
132
  40.4%
267
  40.6%
Asia
35
  10.6%
33
  10.1%
68
  10.3%
Rest of the World
161
  48.6%
162
  49.5%
323
  49.1%
Number of Participants by the Eye (Right or Left) Chosen as the Study Eye  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 331 participants 327 participants 658 participants
Right Eye
168
  50.8%
170
  52.0%
338
  51.4%
Left Eye
163
  49.2%
157
  48.0%
320
  48.6%
Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye   [1] 
Mean (Standard Deviation)
Unit of measure:  ETDRS Letters
Number Analyzed 331 participants 327 participants 658 participants
58.7  (14.0) 58.9  (13.3) 58.8  (13.6)
[1]
Measure Description: Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R). The BCVA letter score ranges from 0 to 100 (best score attainable), with a higher score indicating better visual acuity.
Number of Participants by the BCVA Letter Score Categories in the Study Eye  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 331 participants 327 participants 658 participants
≥74 Letters
45
  13.6%
39
  11.9%
84
  12.8%
73 to 55 Letters
181
  54.7%
183
  56.0%
364
  55.3%
≤54 Letters
105
  31.7%
105
  32.1%
210
  31.9%
Number of Participants by the Low Luminance Deficit (LLD) Letter Score Categories in the Study Eye  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 331 participants 327 participants 658 participants
<33 Letters
238
  71.9%
234
  71.6%
472
  71.7%
≥33 Letters
89
  26.9%
93
  28.4%
182
  27.7%
Missing/Invalid
4
   1.2%
0
   0.0%
4
   0.6%
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye by Fundus Fluorescein Angiography  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 331 participants 327 participants 658 participants
Occult
171
  51.7%
140
  42.8%
311
  47.3%
Classic
98
  29.6%
109
  33.3%
207
  31.5%
Minimally Classic
30
   9.1%
31
   9.5%
61
   9.3%
Retinal Angiomatous Proliferation (RAP)
14
   4.2%
15
   4.6%
29
   4.4%
Predominantly Classic
6
   1.8%
16
   4.9%
22
   3.3%
Polypoidal Choroidal Vasculopathy (PCV)
5
   1.5%
8
   2.4%
13
   2.0%
Missing
7
   2.1%
8
   2.4%
15
   2.3%
1.Primary Outcome
Title Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
Hide Description Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded from analysis. 95% CI is a rounding of 95.03% CI.
Time Frame From Baseline through Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept
Hide Arm/Group Description:
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
Overall Number of Participants Analyzed 331 327
Mean (95% Confidence Interval)
Unit of Measure: ETDRS Letters
6.6
(5.3 to 7.8)
6.6
(5.3 to 7.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Faricimab, Arm B: Aflibercept
Comments A sample size of approximately 320 participants in each arm provided greater than 90% power to show non-inferiority of faricimab to aflibercept in the change from baseline BCVA averaged over Weeks 40, 44, and 48 in the ITT population, using a non-inferiority margin of 4 letters at the one-sided 0.02485 significance level.
Type of Statistical Test Non-Inferiority
Comments If the lower bound of a two-sided 95.03% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.7 to 1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.91
Estimation Comments The adjusted mean difference was calculated as Arm A: Faricimab minus Arm B: Aflibercept.
2.Secondary Outcome
Title Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
Hide Description Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded from analysis. 95% CI is a rounding of 95.03% CI.
Time Frame From Baseline through Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept
Hide Arm/Group Description:
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
Overall Number of Participants Analyzed 331 327
Mean (95% Confidence Interval)
Unit of Measure: ETDRS Letters
6.6
(5.3 to 7.9)
7.1
(5.8 to 8.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Faricimab, Arm B: Aflibercept
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-2.4 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.93
Estimation Comments The adjusted mean difference was calculated as Arm A: Faricimab minus Arm B: Aflibercept.
3.Secondary Outcome
Title Change From Baseline in BCVA in the Study Eye Over Time
Hide Description Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded from analysis. 95% CI is a rounding of 95.03% CI.
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
Hide Description BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, average of Weeks 40, 44, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48 were included in this analysis.
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept
Hide Arm/Group Description:
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
Overall Number of Participants Analyzed 302 291
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Gaining ≥15 Letters
20.2
(15.9 to 24.6)
22.2
(17.7 to 26.8)
Gaining ≥10 Letters
39.2
(34.1 to 44.4)
35.8
(30.6 to 40.9)
Gaining ≥5 Letters
60.5
(55.2 to 65.7)
59.4
(53.9 to 64.9)
Gaining ≥0 Letters
82.2
(77.9 to 86.4)
79.1
(74.5 to 83.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Faricimab, Arm B: Aflibercept
Comments This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab minus Arm B: Aflibercept.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CMH Weighted Percentage
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-8.3 to 4.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm A: Faricimab, Arm B: Aflibercept
Comments This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab minus Arm B: Aflibercept.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CMH Weighted Percentage
Estimated Value 3.4
Confidence Interval (2-Sided) 95%
-3.9 to 10.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm A: Faricimab, Arm B: Aflibercept
Comments This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab minus Arm B: Aflibercept.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CMH Weighted Percentage
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-6.6 to 8.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm A: Faricimab, Arm B: Aflibercept
Comments This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab minus Arm B: Aflibercept.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CMH Weighted Percentage
Estimated Value 3.1
Confidence Interval (2-Sided) 95%
-3.1 to 9.3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
Hide Description BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, average of Weeks 52, 56, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 52, 56, or 60 were included in this analysis.
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept
Hide Arm/Group Description:
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
Overall Number of Participants Analyzed 289 276
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
22.6
(18.1 to 27.1)
23.7
(19.1 to 28.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Faricimab, Arm B: Aflibercept
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CMH Weighted Percentage
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-7.7 to 5.3
Estimation Comments The difference in CMH weighted percentage of participants was calculated as Arm A: Faricimab minus Arm B: Aflibercept.
6.Secondary Outcome
Title Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Hide Description Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Hide Description Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Hide Description Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Hide Description Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
Hide Description Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, average of Weeks 40, 44, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48 were included in this analysis.
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept
Hide Arm/Group Description:
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
Overall Number of Participants Analyzed 302 291
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Avoiding a Loss of ≥15 Letters
95.8
(93.6 to 98.0)
97.3
(95.5 to 99.1)
Avoiding a Loss of ≥10 Letters
93.8
(91.1 to 96.4)
94.6
(92.2 to 97.1)
Avoiding a Loss of ≥5 Letters
91.2
(88.0 to 94.3)
88.5
(85.0 to 92.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Faricimab, Arm B: Aflibercept
Comments This is the difference in the percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab minus Arm B: Aflibercept.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CMH Weighted Percentage
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-4.4 to 1.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm A: Faricimab, Arm B: Aflibercept
Comments This is the difference in the percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab minus Arm B: Aflibercept.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CMH Weighted Percentage
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-4.5 to 2.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm A: Faricimab, Arm B: Aflibercept
Comments This is the difference in the percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab minus Arm B: Aflibercept.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CMH Weighted Percentage
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
-2.1 to 7.3
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
Hide Description Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, average of Weeks 52, 56, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 52, 56, or 60 were included in this analysis.
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept
Hide Arm/Group Description:
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
Overall Number of Participants Analyzed 289 276
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
96.5
(94.4 to 98.6)
96.1
(94.0 to 98.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Faricimab, Arm B: Aflibercept
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CMH Weighted Percentage
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-2.6 to 3.3
Estimation Comments The difference in CMH weighted percentage of participants was calculated as Arm A: Faricimab minus Arm B: Aflibercept.
12.Secondary Outcome
Title Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Hide Description Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Hide Description Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Hide Description Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48
Hide Description BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, average of Weeks 40, 44, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48 were included in this analysis.
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept
Hide Arm/Group Description:
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
Overall Number of Participants Analyzed 302 291
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
24.5
(19.8 to 29.2)
26.2
(21.2 to 31.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Faricimab, Arm B: Aflibercept
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CMH Weighted Percentage
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-8.5 to 5.1
Estimation Comments The difference in CMH weighted percentage of participants was calculated as Arm A: Faricimab minus Arm B: Aflibercept.
16.Secondary Outcome
Title Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Hide Description Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48
Hide Description BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (<69 letters vs. ≥69 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, average of Weeks 40, 44, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48 were included in this analysis.
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept
Hide Arm/Group Description:
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
Overall Number of Participants Analyzed 302 291
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
55.2
(50.1 to 60.2)
49.4
(44.4 to 54.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Faricimab, Arm B: Aflibercept
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CMH Weighted Percentage
Estimated Value 5.7
Confidence Interval (2-Sided) 95%
-1.4 to 12.9
Estimation Comments The difference in CMH weighted percentage of participants was calculated as Arm A: Faricimab minus Arm B: Aflibercept.
18.Secondary Outcome
Title Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Hide Description Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (<69 letters vs. ≥69 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48
Hide Description BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Average of Weeks 40, 44, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48 were included in this analysis.
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept
Hide Arm/Group Description:
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
Overall Number of Participants Analyzed 302 291
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
7.9
(5.0 to 10.8)
7.5
(4.7 to 10.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Faricimab, Arm B: Aflibercept
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CMH Weighted Percentage
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-3.6 to 4.4
Estimation Comments The difference in CMH weighted percentage of participants was calculated as Arm A: Faricimab minus Arm B: Aflibercept.
20.Secondary Outcome
Title Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Hide Description Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Outcome Measure Data Not Reported
21.Secondary Outcome
Title Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals at Week 48
Hide Description [Not Specified]
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all participants randomized to the faricimab arm who completed their Week 48 visit.
Arm/Group Title Arm A: Faricimab
Hide Arm/Group Description:
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
Overall Number of Participants Analyzed 316
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Once Every 8 Weeks
22.2
(17.6 to 26.7)
Once Every 12 Weeks
32.9
(27.7 to 38.1)
Once Every 16 Weeks
44.9
(39.4 to 50.4)
22.Secondary Outcome
Title Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals at Weeks 60 and 112
Hide Description [Not Specified]
Time Frame Weeks 60 and 112
Outcome Measure Data Not Reported
23.Secondary Outcome
Title Number of Study Drug Injections Received in the Study Eye Per Participant Through Week 48
Hide Description [Not Specified]
Time Frame From Baseline through Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept
Hide Arm/Group Description:
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
Overall Number of Participants Analyzed 331 327
Median (Inter-Quartile Range)
Unit of Measure: Injections per participant
7.0
(7.0 to 7.0)
8.0
(8.0 to 8.0)
24.Secondary Outcome
Title Number of Study Drug Injections Received in the Study Eye Per Participant Through Weeks 60 and 112
Hide Description [Not Specified]
Time Frame From Baseline through Weeks 60 and 112
Outcome Measure Data Not Reported
25.Secondary Outcome
Title Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48
Hide Description Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group iteraction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame From Baseline through Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept
Hide Arm/Group Description:
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
Overall Number of Participants Analyzed 331 327
Mean (95% Confidence Interval)
Unit of Measure: microns
-137.1
(-143.1 to -131.2)
-130.8
(-136.8 to -124.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Faricimab, Arm B: Aflibercept
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -6.4
Confidence Interval (2-Sided) 95%
-14.8 to 2.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.30
Estimation Comments The adjusted mean difference was calculated as Arm A: Faricimab minus Arm B: Aflibercept.
26.Secondary Outcome
Title Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60
Hide Description Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame From Baseline through Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept
Hide Arm/Group Description:
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
Overall Number of Participants Analyzed 331 327
Mean (95% Confidence Interval)
Unit of Measure: microns
-135.7
(-141.2 to -130.1)
-137.0
(-142.7 to -131.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Faricimab, Arm B: Aflibercept
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-6.6 to 9.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.05
Estimation Comments The adjusted mean difference was calculated as Arm A: Faricimab minus Arm B: Aflibercept.
27.Secondary Outcome
Title Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Hide Description Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112
Outcome Measure Data Not Reported
28.Secondary Outcome
Title Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Hide Description Intraretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 millimetre [mm]). The weighted estimates of the percentage of participants with absence of intraretinal fluid were based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world). Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
Outcome Measure Data Not Reported
29.Secondary Outcome
Title Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Hide Description Subretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants with absence of intraretinal fluid were based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world). Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
Outcome Measure Data Not Reported
30.Secondary Outcome
Title Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Hide Description Intraretinal fluid and subretinal fluid were measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants with absence of intraretinal fluid were based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world). Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
Outcome Measure Data Not Reported
31.Secondary Outcome
Title Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Hide Description Pigment epithelial detachment was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants with absence of pigment epithelial detachment were based on the Cochran-Mantel Haenszel (CMH) test stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. the rest of the world). Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.03% CI.
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
Outcome Measure Data Not Reported
32.Secondary Outcome
Title Percentage of Participants With Absence of Intraretinal Cysts in the Study Eye Over Time
Hide Description [Not Specified]
Time Frame Up to 112 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The percentage of participants with absence of intraretinal cysts over time was planned but it was not evaluated (i.e., 0 participants analyzed) because the absence of intraretinal fluid and the absence of intraretinal cysts are described by the same variable during reading center grading.
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept
Hide Arm/Group Description:
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
33.Secondary Outcome
Title Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48
Hide Description The total area of the choroidal neovascularization lesion in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with non-missing, valid assessments at Baseline and Week 48 were included in this analysis.
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept
Hide Arm/Group Description:
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
Overall Number of Participants Analyzed 240 236
Mean (Standard Deviation)
Unit of Measure: millimetres squared (mm^2)
0.3  (4.6) 1.1  (4.4)
34.Secondary Outcome
Title Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 112
Hide Description The total area of the choroidal neovascularization lesion in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization.
Time Frame Baseline and Week 112
Outcome Measure Data Not Reported
35.Secondary Outcome
Title Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 48
Hide Description The total area of choroidal neovascularization leakage in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with non-missing, valid assessments at Baseline and Week 48 were included in this analysis.
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept
Hide Arm/Group Description:
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
Overall Number of Participants Analyzed 241 238
Mean (Standard Deviation)
Unit of Measure: millimetres squared (mm^2)
-3.3  (6.6) -2.1  (6.3)
36.Secondary Outcome
Title Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 112
Hide Description The total area of choroidal neovascularization leakage in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization.
Time Frame Baseline and Week 112
Outcome Measure Data Not Reported
37.Secondary Outcome
Title Percentage of Participants With Ocular Adverse Events During the Study
Hide Description [Not Specified]
Time Frame Up to 116 weeks
Outcome Measure Data Not Reported
38.Secondary Outcome
Title Percentage of Participants With Non-Ocular Adverse Events During the Study
Hide Description [Not Specified]
Time Frame Up to 116 weeks
Outcome Measure Data Not Reported
39.Secondary Outcome
Title Plasma Concentration of Faricimab Over Time
Hide Description [Not Specified]
Time Frame Pre-dose at Baseline, Weeks 4, 16, 20, 48, 76, and 112
Outcome Measure Data Not Reported
40.Secondary Outcome
Title Percentage of Participants With Presence of Anti-Drug Antibodies to Faricimab at Baseline and at Anytime Post-Baseline
Hide Description [Not Specified]
Time Frame Pre-dose at Baseline, Weeks 4, 20, 48, 76, and 112
Outcome Measure Data Not Reported
Time Frame From randomization until Week 48 (cutoff for primary completion date)
Adverse Event Reporting Description Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye. AEs are still being collected until the end of the study and the results will be updated within 1 year of the final collection date.
 
Arm/Group Title Arm A: Faricimab Arm B: Aflibercept
Hide Arm/Group Description Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W). Participants randomized to the active comparator (Arm B), a 2 mg dose of aflibercept was administered intravitreally (IVT) Q8W after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period. This will consist of three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
All-Cause Mortality
Arm A: Faricimab Arm B: Aflibercept
Affected / at Risk (%) Affected / at Risk (%)
Total   4/331 (1.21%)      7/326 (2.15%)    
Hide Serious Adverse Events
Arm A: Faricimab Arm B: Aflibercept
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/331 (14.80%)      57/326 (17.48%)    
Blood and lymphatic system disorders     
Anaemia  1  1/331 (0.30%)  1 1/326 (0.31%)  1
Iron deficiency anaemia  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Pancytopenia  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Cardiac disorders     
Acute myocardial infarction  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Angina pectoris  1  1/331 (0.30%)  1 1/326 (0.31%)  3
Atrial fibrillation  1  1/331 (0.30%)  1 2/326 (0.61%)  2
Cardiac failure  1  1/331 (0.30%)  1 3/326 (0.92%)  4
Cardiac failure congestive  1  2/331 (0.60%)  2 4/326 (1.23%)  9
Cardiopulmonary failure  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Congestive cardiomyopathy  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Coronary artery disease  1  1/331 (0.30%)  1 1/326 (0.31%)  1
Dressler's syndrome  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Myocardial infarction  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Myocardial ischaemia  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Palpitations  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Paroxysmal atrioventricular block  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Pericardial effusion  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Pericarditis  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Ventricular extrasystoles  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Ventricular fibrillation  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Eye disorders     
Angle closure glaucoma  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Cataract  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Cataract cortical  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Corneal oedema  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Eye allergy  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Macular degeneration  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Neovascular age-related macular degeneration  1  4/331 (1.21%)  4 0/326 (0.00%)  0
Retinal haemorrhage  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Retinal pigment epithelial tear  1  2/331 (0.60%)  2 0/326 (0.00%)  0
Retinal vein occlusion  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Uveitis  1  1/331 (0.30%)  1 1/326 (0.31%)  1
Vitreous haemorrhage  1  1/331 (0.30%)  1 1/326 (0.31%)  1
Vitritis  1  2/331 (0.60%)  2 0/326 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Ascites  1  0/331 (0.00%)  0 1/326 (0.31%)  3
Constipation  1  0/331 (0.00%)  0 3/326 (0.92%)  4
Diarrhoea  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Diverticulum intestinal  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Gastritis  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Gastrointestinal haemorrhage  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Upper gastrointestinal haemorrhage  1  0/331 (0.00%)  0 1/326 (0.31%)  1
General disorders     
Adverse drug reaction  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Death  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Ill-defined disorder  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Pain  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Hepatobiliary disorders     
Biliary obstruction  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Cholecystitis  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Cholecystitis acute  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Infections and infestations     
Bronchitis  1  0/331 (0.00%)  0 1/326 (0.31%)  1
COVID-19  1  3/331 (0.91%)  3 1/326 (0.31%)  1
Cellulitis  1  0/331 (0.00%)  0 2/326 (0.61%)  2
Chorioretinitis  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Diverticulitis  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Endophthalmitis  1  0/331 (0.00%)  0 2/326 (0.61%)  2
Infectious pleural effusion  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Infective exacerbation of chronic obstructive airways disease  1  0/331 (0.00%)  0 1/326 (0.31%)  2
Influenza  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Necrotising fasciitis  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Osteomyelitis  1  1/331 (0.30%)  1 1/326 (0.31%)  1
Pneumonia  1  1/331 (0.30%)  1 2/326 (0.61%)  2
Pyelonephritis acute  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Sepsis  1  0/331 (0.00%)  0 2/326 (0.61%)  2
Viral uveitis  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Injury, poisoning and procedural complications     
Asbestosis  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Facial bones fracture  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Fall  1  2/331 (0.60%)  2 1/326 (0.31%)  1
Hip fracture  1  2/331 (0.60%)  2 0/326 (0.00%)  0
Injury  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Joint dislocation  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Lumbar vertebral fracture  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Rib fracture  1  0/331 (0.00%)  0 2/326 (0.61%)  2
Upper limb fracture  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Investigations     
Intraocular pressure increased  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Weight decreased  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Metabolism and nutrition disorders     
Fluid overload  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Hyperkalaemia  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Hypokalaemia  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Vitamin B12 deficiency  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Back pain  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Fracture nonunion  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Lumbar spinal stenosis  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Muscular weakness  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Musculoskeletal stiffness  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Osteoarthritis  1  2/331 (0.60%)  2 1/326 (0.31%)  1
Rhabdomyolysis  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Bile duct cancer  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Bladder neoplasm  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Breast cancer stage IV  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Colon adenoma  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Extranodal marginal zone B-cell lymphoma (MALT type)  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Glioblastoma multiforme  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Lung cancer metastatic  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Lung neoplasm malignant  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Metastases to liver  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Ovarian cancer metastatic  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Pancreatic carcinoma  1  1/331 (0.30%)  1 1/326 (0.31%)  1
Sarcomatoid carcinoma  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Sarcomatoid carcinoma of the lung  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Nervous system disorders     
Brain oedema  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Cerebral haemorrhage  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Cerebrovascular accident  1  1/331 (0.30%)  1 3/326 (0.92%)  6
Ischaemic stroke  1  0/331 (0.00%)  0 2/326 (0.61%)  2
Postictal paralysis  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Presyncope  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Seizure  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Subarachnoid haemorrhage  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Syncope  1  1/331 (0.30%)  1 2/326 (0.61%)  3
Thrombotic cerebral infarction  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Transient ischaemic attack  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Product Issues     
Device malfunction  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Psychiatric disorders     
Mixed anxiety and depressive disorder  1  1/331 (0.30%)  1 0/326 (0.00%)  0
Renal and urinary disorders     
Cystitis haemorrhagic  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Reproductive system and breast disorders     
Prostatomegaly  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Bronchiectasis  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Chronic obstructive pulmonary disease  1  1/331 (0.30%)  1 2/326 (0.61%)  2
Dyspnoea  1  0/331 (0.00%)  0 2/326 (0.61%)  2
Hypoxia  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Interstitial lung disease  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Lung perforation  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Pneumonitis  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Vascular disorders     
Hypertension  1  0/331 (0.00%)  0 1/326 (0.31%)  1
Orthostatic hypotension  1  1/331 (0.30%)  1 1/326 (0.31%)  1
1
Term from vocabulary, MedDRA v23.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A: Faricimab Arm B: Aflibercept
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   92/331 (27.79%)      79/326 (24.23%)    
Eye disorders     
Conjunctival haemorrhage  1  29/331 (8.76%)  38 32/326 (9.82%)  50
Neovascular age-related macular degeneration  1  49/331 (14.80%)  54 39/326 (11.96%)  44
Infections and infestations     
Nasopharyngitis  1  24/331 (7.25%)  25 16/326 (4.91%)  17
1
Term from vocabulary, MedDRA v23.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03823300    
Other Study ID Numbers: GR40844
2018-004042-42 ( EudraCT Number )
First Submitted: January 29, 2019
First Posted: January 30, 2019
Results First Submitted: February 25, 2022
Results First Posted: May 4, 2022
Last Update Posted: May 4, 2022