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Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections (MERLIN)

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: NCT03710564
Recruitment Status : Terminated (Sponsor Decision)
First Posted : October 18, 2018
Results First Posted : July 22, 2022
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Age-Related Macular Degeneration
Interventions Biological: Brolucizumab
Biological: Aflibercept
Enrollment 535
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Brolucizumab Aflibercept
Hide Arm/Group Description Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks. Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Period Title: Overall Study
Started [1] 356 179
Completed 172 86
Not Completed 184 93
Reason Not Completed
Study Terminated by Sponsor             104             55
Withdrawal by Subject             57             25
Death             10             4
Lost to Follow-up             5             4
Protocol Violation             3             2
Adverse Event             3             0
Physician Decision             2             3
[1]
All randomized Participants
Arm/Group Title Brolucizumab Aflibercept Total
Hide Arm/Group Description Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks. Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks. Total of all reporting groups
Overall Number of Baseline Participants 356 179 535
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 356 participants 179 participants 535 participants
76.4  (7.47) 76.1  (7.80) 76.3  (7.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 356 participants 179 participants 535 participants
Female
195
  54.8%
107
  59.8%
302
  56.4%
Male
161
  45.2%
72
  40.2%
233
  43.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 356 participants 179 participants 535 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   0.8%
2
   1.1%
5
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   1.1%
0
   0.0%
4
   0.7%
White
347
  97.5%
176
  98.3%
523
  97.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   0.6%
1
   0.6%
3
   0.6%
1.Primary Outcome
Title Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Week 52
Hide Description

BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. A positive change from baseline represents better functioning.

Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. Last observation carried forward (LOCF) was used for the imputation of missing values.

Time Frame Baseline, week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Brolucizumab Aflibercept
Hide Arm/Group Description:
Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Overall Number of Participants Analyzed 356 179
Mean (Standard Deviation)
Unit of Measure: Score on a scale
0.3  (9.02) 0.9  (6.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brolucizumab, Aflibercept
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4537
Comments [Not Specified]
Method Pairwise ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-2.1 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.76
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Stable Visual Acuity (VA) or Improvement in VA at Week 52 and Week 104
Hide Description

Visual Acuity (VA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. VA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of participants with no change or gain in VA compared to baseline was reported. VA stabilization or improvement is defined as a change from baseline no worse than 5 letters loss in VA compared to Baseline.

Baseline VA was defined as the last measurement on or prior to the baseline visit. VA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment.

Time Frame Baseline, weeks 52 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point.
Arm/Group Title Brolucizumab Aflibercept
Hide Arm/Group Description:
Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Overall Number of Participants Analyzed 356 179
Measure Type: Count of Participants
Unit of Measure: Participants
Week 52 Number Analyzed 356 participants 179 participants
232
  65.2%
132
  73.7%
Week 104 Number Analyzed 162 participants 86 participants
122
  75.3%
63
  73.3%
3.Secondary Outcome
Title Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More
Hide Description

BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 5 letters or more from baseline was reported for each post-baseline visit.

Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment.

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 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point.
Arm/Group Title Brolucizumab Aflibercept
Hide Arm/Group Description:
Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Overall Number of Participants Analyzed 356 179
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 353 participants 176 participants
31
   8.8%
16
   9.1%
Week 8 Number Analyzed 347 participants 174 participants
38
  11.0%
17
   9.8%
Week 12 Number Analyzed 343 participants 176 participants
33
   9.6%
22
  12.5%
Week 16 Number Analyzed 341 participants 173 participants
34
  10.0%
19
  11.0%
Week 20 Number Analyzed 340 participants 171 participants
47
  13.8%
15
   8.8%
Week 24 Number Analyzed 324 participants 168 participants
40
  12.3%
20
  11.9%
Week 28 Number Analyzed 327 participants 174 participants
46
  14.1%
24
  13.8%
Week 32 Number Analyzed 317 participants 166 participants
45
  14.2%
24
  14.5%
Week 36 Number Analyzed 308 participants 166 participants
44
  14.3%
24
  14.5%
Week 40 Number Analyzed 299 participants 165 participants
46
  15.4%
17
  10.3%
Week 44 Number Analyzed 293 participants 157 participants
45
  15.4%
17
  10.8%
Week 48 Number Analyzed 289 participants 153 participants
46
  15.9%
23
  15.0%
Week 52 Number Analyzed 282 participants 156 participants
50
  17.7%
24
  15.4%
Week 56 Number Analyzed 263 participants 139 participants
46
  17.5%
17
  12.2%
Week 60 Number Analyzed 267 participants 141 participants
51
  19.1%
23
  16.3%
Week 64 Number Analyzed 266 participants 142 participants
47
  17.7%
26
  18.3%
Week 68 Number Analyzed 262 participants 139 participants
50
  19.1%
28
  20.1%
Week 72 Number Analyzed 255 participants 141 participants
59
  23.1%
25
  17.7%
Week 76 Number Analyzed 260 participants 138 participants
48
  18.5%
31
  22.5%
Week 80 Number Analyzed 249 participants 136 participants
49
  19.7%
27
  19.9%
Week 84 Number Analyzed 243 participants 129 participants
51
  21.0%
27
  20.9%
Week 88 Number Analyzed 225 participants 124 participants
37
  16.4%
24
  19.4%
Week 92 Number Analyzed 211 participants 112 participants
43
  20.4%
24
  21.4%
Week 96 Number Analyzed 198 participants 101 participants
42
  21.2%
19
  18.8%
Week 100 Number Analyzed 174 participants 91 participants
40
  23.0%
19
  20.9%
Week 104 Number Analyzed 162 participants 86 participants
40
  24.7%
23
  26.7%
4.Secondary Outcome
Title Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More
Hide Description

BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 10 letters or more from baseline was reported for each post-baseline visit.

Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment.

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 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point.
Arm/Group Title Brolucizumab Aflibercept
Hide Arm/Group Description:
Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Overall Number of Participants Analyzed 356 179
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 353 participants 176 participants
4
   1.1%
6
   3.4%
Week 8 Number Analyzed 347 participants 174 participants
5
   1.4%
5
   2.9%
Week 12 Number Analyzed 343 participants 176 participants
9
   2.6%
5
   2.8%
Week 16 Number Analyzed 341 participants 173 participants
13
   3.8%
4
   2.3%
Week 20 Number Analyzed 340 participants 171 participants
14
   4.1%
5
   2.9%
Week 24 Number Analyzed 324 participants 168 participants
8
   2.5%
6
   3.6%
Week 28 Number Analyzed 327 participants 174 participants
14
   4.3%
9
   5.2%
Week 32 Number Analyzed 317 participants 166 participants
10
   3.2%
8
   4.8%
Week 36 Number Analyzed 308 participants 166 participants
9
   2.9%
10
   6.0%
Week 40 Number Analyzed 299 participants 165 participants
13
   4.3%
5
   3.0%
Week 44 Number Analyzed 293 participants 157 participants
17
   5.8%
6
   3.8%
Week 48 Number Analyzed 289 participants 153 participants
20
   6.9%
9
   5.9%
Week 52 Number Analyzed 282 participants 156 participants
24
   8.5%
7
   4.5%
Week 56 Number Analyzed 263 participants 139 participants
20
   7.6%
5
   3.6%
Week 60 Number Analyzed 267 participants 141 participants
21
   7.9%
8
   5.7%
Week 64 Number Analyzed 266 participants 142 participants
24
   9.0%
10
   7.0%
Week 68 Number Analyzed 262 participants 139 participants
20
   7.6%
10
   7.2%
Week 72 Number Analyzed 255 participants 141 participants
21
   8.2%
11
   7.8%
Week 76 Number Analyzed 260 participants 138 participants
24
   9.2%
13
   9.4%
Week 80 Number Analyzed 249 participants 136 participants
26
  10.4%
13
   9.6%
Week 84 Number Analyzed 243 participants 129 participants
20
   8.2%
10
   7.8%
Week 88 Number Analyzed 225 participants 124 participants
21
   9.3%
14
  11.3%
Week 92 Number Analyzed 211 participants 112 participants
20
   9.5%
9
   8.0%
Week 96 Number Analyzed 198 participants 101 participants
18
   9.1%
8
   7.9%
Week 100 Number Analyzed 174 participants 91 participants
15
   8.6%
7
   7.7%
Week 104 Number Analyzed 162 participants 86 participants
17
  10.5%
7
   8.1%
5.Secondary Outcome
Title Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More
Hide Description

BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 15 letters or more from baseline was reported for each post-baseline visit.

Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment.

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 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point.
Arm/Group Title Brolucizumab Aflibercept
Hide Arm/Group Description:
Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Overall Number of Participants Analyzed 356 179
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 353 participants 176 participants
2
   0.6%
1
   0.6%
Week 8 Number Analyzed 347 participants 174 participants
2
   0.6%
1
   0.6%
Week 12 Number Analyzed 343 participants 176 participants
3
   0.9%
2
   1.1%
Week 16 Number Analyzed 341 participants 173 participants
4
   1.2%
1
   0.6%
Week 20 Number Analyzed 340 participants 171 participants
5
   1.5%
1
   0.6%
Week 24 Number Analyzed 324 participants 168 participants
3
   0.9%
1
   0.6%
Week 28 Number Analyzed 327 participants 174 participants
4
   1.2%
3
   1.7%
Week 32 Number Analyzed 317 participants 166 participants
6
   1.9%
3
   1.8%
Week 36 Number Analyzed 308 participants 166 participants
3
   1.0%
4
   2.4%
Week 40 Number Analyzed 299 participants 165 participants
5
   1.7%
3
   1.8%
Week 44 Number Analyzed 293 participants 157 participants
6
   2.0%
3
   1.9%
Week 48 Number Analyzed 289 participants 153 participants
10
   3.5%
3
   2.0%
Week 52 Number Analyzed 282 participants 156 participants
14
   5.0%
2
   1.3%
Week 56 Number Analyzed 263 participants 139 participants
13
   4.9%
2
   1.4%
Week 60 Number Analyzed 267 participants 141 participants
13
   4.9%
3
   2.1%
Week 64 Number Analyzed 266 participants 142 participants
10
   3.8%
4
   2.8%
Week 68 Number Analyzed 262 participants 139 participants
10
   3.8%
4
   2.9%
Week 72 Number Analyzed 255 participants 141 participants
10
   3.9%
3
   2.1%
Week 76 Number Analyzed 260 participants 138 participants
13
   5.0%
4
   2.9%
Week 80 Number Analyzed 249 participants 136 participants
12
   4.8%
4
   2.9%
Week 84 Number Analyzed 243 participants 129 participants
7
   2.9%
6
   4.7%
Week 88 Number Analyzed 225 participants 124 participants
10
   4.4%
5
   4.0%
Week 92 Number Analyzed 211 participants 112 participants
11
   5.2%
4
   3.6%
Week 96 Number Analyzed 198 participants 101 participants
9
   4.5%
4
   4.0%
Week 100 Number Analyzed 174 participants 91 participants
7
   4.0%
5
   5.5%
Week 104 Number Analyzed 162 participants 86 participants
10
   6.2%
4
   4.7%
6.Secondary Outcome
Title Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More
Hide Description

BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 5 letters or more from baseline was reported for each post-baseline visit.

Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment.

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 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point.
Arm/Group Title Brolucizumab Aflibercept
Hide Arm/Group Description:
Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Overall Number of Participants Analyzed 356 179
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 353 participants 176 participants
94
  26.6%
35
  19.9%
Week 8 Number Analyzed 347 participants 174 participants
98
  28.2%
43
  24.7%
Week 12 Number Analyzed 343 participants 176 participants
113
  32.9%
48
  27.3%
Week 16 Number Analyzed 341 participants 173 participants
119
  34.9%
53
  30.6%
Week 20 Number Analyzed 340 participants 171 participants
123
  36.2%
47
  27.5%
Week 24 Number Analyzed 324 participants 168 participants
125
  38.6%
57
  33.9%
Week 28 Number Analyzed 327 participants 174 participants
129
  39.4%
61
  35.1%
Week 32 Number Analyzed 317 participants 166 participants
122
  38.5%
57
  34.3%
Week 36 Number Analyzed 308 participants 166 participants
108
  35.1%
58
  34.9%
Week 40 Number Analyzed 299 participants 165 participants
111
  37.1%
62
  37.6%
Week 44 Number Analyzed 293 participants 157 participants
103
  35.2%
50
  31.8%
Week 48 Number Analyzed 289 participants 153 participants
117
  40.5%
54
  35.3%
Week 52 Number Analyzed 282 participants 156 participants
108
  38.3%
52
  33.3%
Week 56 Number Analyzed 263 participants 139 participants
103
  39.2%
48
  34.5%
Week 60 Number Analyzed 267 participants 141 participants
108
  40.4%
46
  32.6%
Week 64 Number Analyzed 266 participants 142 participants
106
  39.8%
51
  35.9%
Week 68 Number Analyzed 262 participants 139 participants
96
  36.6%
46
  33.1%
Week 72 Number Analyzed 255 participants 141 participants
108
  42.4%
46
  32.6%
Week 76 Number Analyzed 260 participants 138 participants
107
  41.2%
48
  34.8%
Week 80 Number Analyzed 249 participants 136 participants
106
  42.6%
50
  36.8%
Week 84 Number Analyzed 243 participants 129 participants
102
  42.0%
43
  33.3%
Week 88 Number Analyzed 225 participants 124 participants
93
  41.3%
42
  33.9%
Week 92 Number Analyzed 211 participants 112 participants
79
  37.4%
36
  32.1%
Week 96 Number Analyzed 198 participants 101 participants
76
  38.4%
31
  30.7%
Week 100 Number Analyzed 174 participants 91 participants
70
  40.2%
24
  26.4%
Week 104 Number Analyzed 162 participants 86 participants
65
  40.1%
28
  32.6%
7.Secondary Outcome
Title Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More
Hide Description

BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 10 letters or more from baseline was reported for each post-baseline visit.

Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment.

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 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point.
Arm/Group Title Brolucizumab Aflibercept
Hide Arm/Group Description:
Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Overall Number of Participants Analyzed 356 179
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 353 participants 176 participants
48
  13.6%
18
  10.2%
Week 8 Number Analyzed 347 participants 174 participants
49
  14.1%
20
  11.5%
Week 12 Number Analyzed 343 participants 176 participants
62
  18.1%
20
  11.4%
Week 16 Number Analyzed 341 participants 173 participants
64
  18.8%
28
  16.2%
Week 20 Number Analyzed 340 participants 171 participants
67
  19.7%
26
  15.2%
Week 24 Number Analyzed 324 participants 168 participants
77
  23.8%
34
  20.2%
Week 28 Number Analyzed 327 participants 174 participants
78
  23.9%
36
  20.7%
Week 32 Number Analyzed 317 participants 166 participants
75
  23.7%
38
  22.9%
Week 36 Number Analyzed 308 participants 166 participants
69
  22.4%
38
  22.9%
Week 40 Number Analyzed 299 participants 165 participants
65
  21.7%
37
  22.4%
Week 44 Number Analyzed 293 participants 157 participants
60
  20.5%
31
  19.7%
Week 48 Number Analyzed 289 participants 153 participants
66
  22.8%
34
  22.2%
Week 52 Number Analyzed 282 participants 156 participants
67
  23.8%
32
  20.5%
Week 56 Number Analyzed 263 participants 139 participants
71
  27.0%
31
  22.3%
Week 60 Number Analyzed 267 participants 141 participants
67
  25.1%
26
  18.4%
Week 64 Number Analyzed 266 participants 142 participants
72
  27.1%
28
  19.7%
Week 68 Number Analyzed 262 participants 139 participants
61
  23.3%
31
  22.3%
Week 72 Number Analyzed 255 participants 141 participants
62
  24.3%
29
  20.6%
Week 76 Number Analyzed 260 participants 138 participants
62
  23.8%
24
  17.4%
Week 80 Number Analyzed 249 participants 136 participants
66
  26.5%
29
  21.3%
Week 84 Number Analyzed 243 participants 129 participants
59
  24.3%
29
  22.5%
Week 88 Number Analyzed 225 participants 124 participants
53
  23.6%
24
  19.4%
Week 92 Number Analyzed 211 participants 112 participants
46
  21.8%
21
  18.8%
Week 96 Number Analyzed 198 participants 101 participants
50
  25.3%
18
  17.8%
Week 100 Number Analyzed 174 participants 91 participants
39
  22.4%
15
  16.5%
Week 104 Number Analyzed 162 participants 86 participants
42
  25.9%
19
  22.1%
8.Secondary Outcome
Title Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More
Hide Description

BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 15 letters or more from baseline was reported for each post-baseline visit.

Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment.

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 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point.
Arm/Group Title Brolucizumab Aflibercept
Hide Arm/Group Description:
Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Overall Number of Participants Analyzed 356 179
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 353 participants 176 participants
43
  12.2%
14
   8.0%
Week 8 Number Analyzed 347 participants 174 participants
37
  10.7%
16
   9.2%
Week 12 Number Analyzed 343 participants 176 participants
51
  14.9%
16
   9.1%
Week 16 Number Analyzed 341 participants 173 participants
56
  16.4%
23
  13.3%
Week 20 Number Analyzed 340 participants 171 participants
51
  15.0%
15
   8.8%
Week 24 Number Analyzed 324 participants 168 participants
64
  19.8%
25
  14.9%
Week 28 Number Analyzed 327 participants 174 participants
63
  19.3%
28
  16.1%
Week 32 Number Analyzed 317 participants 166 participants
57
  18.0%
25
  15.1%
Week 36 Number Analyzed 308 participants 166 participants
50
  16.2%
26
  15.7%
Week 40 Number Analyzed 299 participants 165 participants
54
  18.1%
26
  15.8%
Week 44 Number Analyzed 293 participants 157 participants
47
  16.0%
27
  17.2%
Week 48 Number Analyzed 289 participants 153 participants
50
  17.3%
22
  14.4%
Week 52 Number Analyzed 282 participants 156 participants
50
  17.7%
27
  17.3%
Week 56 Number Analyzed 263 participants 139 participants
56
  21.3%
22
  15.8%
Week 60 Number Analyzed 267 participants 141 participants
56
  21.0%
21
  14.9%
Week 64 Number Analyzed 266 participants 142 participants
58
  21.8%
22
  15.5%
Week 68 Number Analyzed 262 participants 139 participants
50
  19.1%
23
  16.5%
Week 72 Number Analyzed 255 participants 141 participants
49
  19.2%
19
  13.5%
Week 76 Number Analyzed 260 participants 138 participants
54
  20.8%
14
  10.1%
Week 80 Number Analyzed 249 participants 136 participants
53
  21.3%
20
  14.7%
Week 84 Number Analyzed 243 participants 129 participants
44
  18.1%
18
  14.0%
Week 88 Number Analyzed 225 participants 124 participants
46
  20.4%
18
  14.5%
Week 92 Number Analyzed 211 participants 112 participants
42
  19.9%
14
  12.5%
Week 96 Number Analyzed 198 participants 101 participants
39
  19.7%
11
  10.9%
Week 100 Number Analyzed 174 participants 91 participants
30
  17.2%
11
  12.1%
Week 104 Number Analyzed 162 participants 86 participants
30
  18.5%
14
  16.3%
9.Secondary Outcome
Title Change in Central Subfield Thickness (CST) From Baseline
Hide Description CST was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. A negative change from baseline is a favorable outcome. CST assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data.
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 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Brolucizumab Aflibercept
Hide Arm/Group Description:
Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Overall Number of Participants Analyzed 356 178
Least Squares Mean (Standard Error)
Unit of Measure: µm
Week 4 -55.1  (2.93) -29.8  (4.15)
Week 8 -59.7  (3.16) -35.4  (4.48)
Week 12 -62.3  (3.24) -37.3  (4.59)
Week 16 -61.7  (3.36) -39.2  (4.75)
Week 20 -64.6  (3.46) -41.4  (4.90)
Week 24 -63.8  (3.61) -40.8  (5.11)
Week 28 -64.3  (3.57) -35.5  (5.05)
Week 32 -65.2  (3.70) -40.4  (5.23)
Week 36 -64.0  (3.81) -42.3  (5.39)
Week 40 -64.9  (3.76) -38.2  (5.32)
Week 44 -66.7  (3.71) -40.2  (5.24)
Week 48 -68.9  (3.76) -40.7  (5.32)
Week 52 -69.0  (3.88) -37.0  (5.50)
Week 56 -70.5  (3.85) -43.9  (5.45)
Week 60 -70.0  (4.00) -43.6  (5.66)
Week 64 -71.2  (3.99) -41.5  (5.65)
Week 68 -71.3  (4.07) -40.8  (5.77)
Week 72 -71.2  (4.08) -42.6  (5.78)
Week 76 -71.4  (4.06) -46.2  (5.76)
Week 80 -72.0  (4.13) -45.3  (5.85)
Week 84 -71.3  (4.15) -48.4  (5.88)
Week 88 -70.9  (4.14) -44.6  (5.87)
Week 92 -69.1  (4.21) -46.4  (5.97)
Week 96 -70.5  (4.13) -43.5  (5.85)
Week 100 -69.8  (4.14) -47.0  (5.87)
Week 104 -71.3  (4.16) -48.3  (5.90)
10.Secondary Outcome
Title Number of Participants With Intraretinal Fluid (IRF)
Hide Description IRF was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with presence of IRF was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data.
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 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point.
Arm/Group Title Brolucizumab Aflibercept
Hide Arm/Group Description:
Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Overall Number of Participants Analyzed 356 179
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 349 participants 175 participants
272
  77.9%
132
  75.4%
Week 8 Number Analyzed 354 participants 178 participants
276
  78.0%
131
  73.6%
Week 12 Number Analyzed 354 participants 178 participants
279
  78.8%
125
  70.2%
Week 16 Number Analyzed 354 participants 178 participants
274
  77.4%
126
  70.8%
Week 20 Number Analyzed 354 participants 178 participants
266
  75.1%
124
  69.7%
Week 24 Number Analyzed 354 participants 178 participants
266
  75.1%
126
  70.8%
Week 28 Number Analyzed 354 participants 178 participants
266
  75.1%
128
  71.9%
Week 32 Number Analyzed 354 participants 178 participants
262
  74.0%
124
  69.7%
Week 36 Number Analyzed 354 participants 178 participants
255
  72.0%
124
  69.7%
Week 40 Number Analyzed 354 participants 178 participants
255
  72.0%
121
  68.0%
Week 44 Number Analyzed 354 participants 178 participants
263
  74.3%
122
  68.5%
Week 48 Number Analyzed 354 participants 178 participants
265
  74.9%
117
  65.7%
Week 52 Number Analyzed 355 participants 178 participants
265
  74.6%
120
  67.4%
Week 56 Number Analyzed 355 participants 178 participants
268
  75.5%
125
  70.2%
Week 60 Number Analyzed 355 participants 178 participants
278
  78.3%
125
  70.2%
Week 64 Number Analyzed 355 participants 178 participants
276
  77.7%
126
  70.8%
Week 68 Number Analyzed 355 participants 178 participants
269
  75.8%
127
  71.3%
Week 72 Number Analyzed 355 participants 178 participants
271
  76.3%
123
  69.1%
Week 76 Number Analyzed 355 participants 178 participants
279
  78.6%
122
  68.5%
Week 80 Number Analyzed 355 participants 178 participants
280
  78.9%
122
  68.5%
Week 84 Number Analyzed 355 participants 178 participants
274
  77.2%
124
  69.7%
Week 88 Number Analyzed 355 participants 178 participants
270
  76.1%
122
  68.5%
Week 92 Number Analyzed 355 participants 178 participants
273
  76.9%
123
  69.1%
Week 96 Number Analyzed 355 participants 178 participants
270
  76.1%
123
  69.1%
Week 100 Number Analyzed 355 participants 178 participants
275
  77.5%
126
  70.8%
Week 104 Number Analyzed 355 participants 178 participants
273
  76.9%
124
  69.7%
11.Secondary Outcome
Title Number of Participants With Subretinal Fluid (SRF)
Hide Description SRF was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with presence of SRF was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data.
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 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point.
Arm/Group Title Brolucizumab Aflibercept
Hide Arm/Group Description:
Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Overall Number of Participants Analyzed 356 179
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 350 participants 176 participants
161
  46.0%
41
  23.3%
Week 8 Number Analyzed 354 participants 178 participants
193
  54.5%
47
  26.4%
Week 12 Number Analyzed 354 participants 178 participants
205
  57.9%
46
  25.8%
Week 16 Number Analyzed 354 participants 178 participants
209
  59.0%
60
  33.7%
Week 20 Number Analyzed 354 participants 178 participants
200
  56.5%
53
  29.8%
Week 24 Number Analyzed 354 participants 178 participants
211
  59.6%
59
  33.1%
Week 28 Number Analyzed 354 participants 178 participants
207
  58.5%
54
  30.3%
Week 32 Number Analyzed 354 participants 178 participants
211
  59.6%
55
  30.9%
Week 36 Number Analyzed 354 participants 178 participants
200
  56.5%
69
  38.8%
Week 40 Number Analyzed 354 participants 178 participants
211
  59.6%
59
  33.1%
Week 44 Number Analyzed 354 participants 178 participants
211
  59.6%
58
  32.6%
Week 48 Number Analyzed 354 participants 178 participants
205
  57.9%
62
  34.8%
Week 52 Number Analyzed 355 participants 178 participants
203
  57.2%
65
  36.5%
Week 56 Number Analyzed 355 participants 178 participants
211
  59.4%
65
  36.5%
Week 60 Number Analyzed 355 participants 178 participants
207
  58.3%
64
  36.0%
Week 64 Number Analyzed 355 participants 178 participants
213
  60.0%
63
  35.4%
Week 68 Number Analyzed 355 participants 178 participants
212
  59.7%
64
  36.0%
Week 72 Number Analyzed 355 participants 178 participants
216
  60.8%
72
  40.4%
Week 76 Number Analyzed 355 participants 178 participants
220
  62.0%
67
  37.6%
Week 80 Number Analyzed 355 participants 178 participants
220
  62.0%
66
  37.1%
Week 84 Number Analyzed 355 participants 178 participants
228
  64.2%
67
  37.6%
Week 88 Number Analyzed 355 participants 178 participants
225
  63.4%
73
  41.0%
Week 92 Number Analyzed 355 participants 178 participants
222
  62.5%
75
  42.1%
Week 96 Number Analyzed 355 participants 178 participants
224
  63.1%
73
  41.0%
Week 100 Number Analyzed 355 participants 178 participants
223
  62.8%
74
  41.6%
Week 104 Number Analyzed 355 participants 178 participants
227
  63.9%
79
  44.4%
12.Secondary Outcome
Title Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid
Hide Description Sub-RPE fluid was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with presence of sub-RPE fluid in participants with sub-RPE fluid at baseline was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data.
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 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point.
Arm/Group Title Brolucizumab Aflibercept
Hide Arm/Group Description:
Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Overall Number of Participants Analyzed 356 179
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 350 participants 176 participants
191
  54.6%
89
  50.6%
Week 8 Number Analyzed 354 participants 178 participants
213
  60.2%
98
  55.1%
Week 12 Number Analyzed 354 participants 178 participants
223
  63.0%
98
  55.1%
Week 16 Number Analyzed 354 participants 178 participants
235
  66.4%
105
  59.0%
Week 20 Number Analyzed 354 participants 178 participants
232
  65.5%
99
  55.6%
Week 24 Number Analyzed 354 participants 178 participants
231
  65.3%
101
  56.7%
Week 28 Number Analyzed 354 participants 178 participants
229
  64.7%
95
  53.4%
Week 32 Number Analyzed 354 participants 178 participants
237
  66.9%
101
  56.7%
Week 36 Number Analyzed 354 participants 178 participants
227
  64.1%
101
  56.7%
Week 40 Number Analyzed 354 participants 178 participants
238
  67.2%
101
  56.7%
Week 44 Number Analyzed 354 participants 178 participants
235
  66.4%
103
  57.9%
Week 48 Number Analyzed 354 participants 178 participants
228
  64.4%
105
  59.0%
Week 52 Number Analyzed 355 participants 178 participants
228
  64.2%
113
  63.5%
Week 56 Number Analyzed 355 participants 178 participants
240
  67.6%
102
  57.3%
Week 60 Number Analyzed 355 participants 178 participants
238
  67.0%
107
  60.1%
Week 64 Number Analyzed 355 participants 178 participants
235
  66.2%
99
  55.6%
Week 68 Number Analyzed 355 participants 178 participants
231
  65.1%
98
  55.1%
Week 72 Number Analyzed 355 participants 178 participants
236
  66.5%
96
  53.9%
Week 76 Number Analyzed 355 participants 178 participants
233
  65.6%
96
  53.9%
Week 80 Number Analyzed 355 participants 178 participants
234
  65.9%
96
  53.9%
Week 84 Number Analyzed 355 participants 178 participants
233
  65.6%
100
  56.2%
Week 88 Number Analyzed 355 participants 178 participants
234
  65.9%
97
  54.5%
Week 92 Number Analyzed 355 participants 178 participants
236
  66.5%
94
  52.8%
Week 96 Number Analyzed 355 participants 178 participants
237
  66.8%
101
  56.7%
Week 100 Number Analyzed 355 participants 178 participants
242
  68.2%
104
  58.4%
Week 104 Number Analyzed 355 participants 178 participants
237
  66.8%
100
  56.2%
13.Secondary Outcome
Title Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid)
Hide Description Intraretinal fluid (IRF), Subretinal fluid (SRF) and Sub-Retinal Pigment Epithelium fluid (sub-RPE) were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with fluid-free status (simultaneous absence of IRF, SRF, and sub-RPE) was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data.
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 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point.
Arm/Group Title Brolucizumab Aflibercept
Hide Arm/Group Description:
Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Overall Number of Participants Analyzed 356 179
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 347 participants 175 participants
82
  23.6%
16
   9.1%
Week 8 Number Analyzed 354 participants 178 participants
110
  31.1%
24
  13.5%
Week 12 Number Analyzed 354 participants 178 participants
120
  33.9%
22
  12.4%
Week 16 Number Analyzed 354 participants 178 participants
126
  35.6%
23
  12.9%
Week 20 Number Analyzed 354 participants 178 participants
114
  32.2%
20
  11.2%
Week 24 Number Analyzed 354 participants 178 participants
122
  34.5%
28
  15.7%
Week 28 Number Analyzed 354 participants 178 participants
124
  35.0%
23
  12.9%
Week 32 Number Analyzed 354 participants 178 participants
123
  34.7%
24
  13.5%
Week 36 Number Analyzed 354 participants 178 participants
111
  31.4%
32
  18.0%
Week 40 Number Analyzed 354 participants 178 participants
117
  33.1%
23
  12.9%
Week 44 Number Analyzed 354 participants 178 participants
122
  34.5%
25
  14.0%
Week 48 Number Analyzed 354 participants 178 participants
116
  32.8%
27
  15.2%
Week 52 Number Analyzed 355 participants 178 participants
107
  30.1%
25
  14.0%
Week 56 Number Analyzed 355 participants 178 participants
127
  35.8%
28
  15.7%
Week 60 Number Analyzed 355 participants 178 participants
125
  35.2%
30
  16.9%
Week 64 Number Analyzed 355 participants 178 participants
129
  36.3%
28
  15.7%
Week 68 Number Analyzed 355 participants 178 participants
124
  34.9%
28
  15.7%
Week 72 Number Analyzed 355 participants 178 participants
133
  37.5%
31
  17.4%
Week 76 Number Analyzed 355 participants 178 participants
133
  37.5%
25
  14.0%
Week 80 Number Analyzed 355 participants 178 participants
136
  38.3%
26
  14.6%
Week 84 Number Analyzed 355 participants 178 participants
135
  38.0%
27
  15.2%
Week 88 Number Analyzed 355 participants 178 participants
130
  36.6%
32
  18.0%
Week 92 Number Analyzed 355 participants 178 participants
128
  36.1%
31
  17.4%
Week 96 Number Analyzed 355 participants 178 participants
127
  35.8%
32
  18.0%
Week 100 Number Analyzed 355 participants 178 participants
130
  36.6%
34
  19.1%
Week 104 Number Analyzed 355 participants 178 participants
134
  37.7%
38
  21.3%
14.Secondary Outcome
Title Time to First Dry Retina (no IRF or SRF)
Hide Description Intraretinal fluid (IRF) and Subretinal fluid (SRF) were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. A dry retina is defined as no IRF or SRF at the respective visit. Kaplan-Meier method was used for estimate of percentiles with 95% CI based on methodology of Brookmeyer and Crowley. Data was censored at the last time when IRF/SRF assessments for fluid-free retina were available for participants who discontinued on/or prior to the time of the start of alternative anti-VEGF treatment. IRF and SRF assessments on unscheduled visits were considered.
Time Frame Baseline, Up to Week 104 (assessments every 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Brolucizumab Aflibercept
Hide Arm/Group Description:
Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Overall Number of Participants Analyzed 356 179
Median (95% Confidence Interval)
Unit of Measure: Days
87.0
(63.0 to 117.0)
646.0 [1] 
(372.0 to NA)
[1]
Not estimable, the percentage of participants achieving the event did not reach the required threshold.
15.Secondary Outcome
Title Time to Sustained Dry Retina (no IRF or SRF at ≥ 2 Consecutive Visits)
Hide Description Intraretinal fluid (IRF) and Subretinal fluid (SRF) were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. A sustained dry retina is defined as no IRF or SRF at 2 or more consecutive visits. Kaplan-Meier method was used for estimate of percentiles with 95% CI based on methodology of Brookmeyer and Crowley. Data was censored at the last time when IRF/SRF assessments for fluid-free retina were available for participants who discontinued on/or prior to the time of the start of alternative anti-VEGF treatment. IRF and SRF assessments on unscheduled visits were considered.
Time Frame Baseline, Up to Week 104 (assessments every 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Brolucizumab Aflibercept
Hide Arm/Group Description:
Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Overall Number of Participants Analyzed 356 179
Median (95% Confidence Interval)
Unit of Measure: Days
148.0
(108.0 to 203.0)
NA [1] 
(NA to NA)
[1]
Not estimable, the percentage of participants achieving the event did not reach the required threshold.
16.Secondary Outcome
Title Number of Participants With Anti-drug Antibody (ADA) Negative Status
Hide Description A blood sample was collected for anti-drug antibody assessment. ADA negative status = ADA negative result at the corresponding study visit. The baseline sample was collected prior to first dose of study treatment and the post-baseline assessments were taken at the scheduled timepoints. A negative Titer was used to assess the ADA status for the brolucizumab arm.
Time Frame Baseline, weeks 4, 12, 24, 36, 52, 76 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. This outcome measure was pre-specified for the brolucizumab arm only.
Arm/Group Title Brolucizumab
Hide Arm/Group Description:
Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Overall Number of Participants Analyzed 356
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 348 participants
77
  22.1%
Week 4 Number Analyzed 347 participants
121
  34.9%
Week 12 Number Analyzed 341 participants
122
  35.8%
Week 24 Number Analyzed 324 participants
118
  36.4%
Week 36 Number Analyzed 308 participants
117
  38.0%
Week 52 Number Analyzed 287 participants
106
  36.9%
Week 76 Number Analyzed 261 participants
100
  38.3%
Week 104 Number Analyzed 236 participants
101
  42.8%
17.Secondary Outcome
Title Free Brolucizumab Serum Concentration
Hide Description

A blood sample was collected for Free Brolucizumab serum concentration assessment. This outcome measure was pre-specified for the brolucizumab arm only. The baseline sample was collected prior to first dose of study treatment and the post-baseline assessments.

Values below the limit of quantification (BLQ) (<0.5 ng/mL) were replaced by one half of the LLOQ (0.25 ng/mL) in the calculation of the summary statistics. For the Mean score at each visit, if the calculated value was less than 0.5, then "NA" was displayed instead; meaning that the score is below the limit of quantitation (<0.5 ng/mL).

Time Frame pre-dose a baseline, weeks 4, 12, 24, 36, 52, 76 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. This outcome measure was pre-specified for the brolucizumab arm only.
Arm/Group Title Brolucizumab
Hide Arm/Group Description:
Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
Overall Number of Participants Analyzed 356
Mean (Standard Deviation)
Unit of Measure: ng / mL
Baseline Number Analyzed 346 participants
NA [1]   (NA)
Week 4 Number Analyzed 347 participants
0.69  (2.47)
Week 12 Number Analyzed 340 participants
0.81  (2.33)
Week 24 Number Analyzed 324 participants
0.69  (2.10)
Week 36 Number Analyzed 308 participants
0.54  (1.32)
Week 52 Number Analyzed 287 participants
NA [1]   (NA)
Week 76 Number Analyzed 261 participants
NA [1]   (NA)
Week 104 Number Analyzed 235 participants
NA [1]   (NA)
[1]
Below the limit of quantitation (<0.5 ng/mL)
Time Frame Adverse events were reported from the start of treatment to 4 weeks after end of treatment, assessed up to maximum duration of 104 weeks.
Adverse Event Reporting Description Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
 
Arm/Group Title Brolucizumab 6mg Aflibercept 2mg Overall
Hide Arm/Group Description Brolucizumab 6mg Aflibercept 2mg Overall
All-Cause Mortality
Brolucizumab 6mg Aflibercept 2mg Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/356 (2.81%)   4/179 (2.23%)   14/535 (2.62%) 
Hide Serious Adverse Events
Brolucizumab 6mg Aflibercept 2mg Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   75/356 (21.07%)   45/179 (25.14%)   120/535 (22.43%) 
Blood and lymphatic system disorders       
Anaemia  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Cardiac disorders       
Acute left ventricular failure  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Angina pectoris  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Angina unstable  1  2/356 (0.56%)  0/179 (0.00%)  2/535 (0.37%) 
Atrial fibrillation  1  1/356 (0.28%)  3/179 (1.68%)  4/535 (0.75%) 
Cardiac arrest  1  1/356 (0.28%)  1/179 (0.56%)  2/535 (0.37%) 
Cardiac failure congestive  1  2/356 (0.56%)  1/179 (0.56%)  3/535 (0.56%) 
Left ventricular failure  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Myocardial infarction  1  2/356 (0.56%)  0/179 (0.00%)  2/535 (0.37%) 
Sinus node dysfunction  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Stress cardiomyopathy  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Ventricular extrasystoles  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Eye disorders       
Angle closure glaucoma - Study eye  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Anterior chamber cell - Study eye  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Anterior chamber flare - Study eye  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Cataract - Fellow eye  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Cataract - Study eye  1  1/356 (0.28%)  1/179 (0.56%)  2/535 (0.37%) 
Glaucoma - Study eye  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Iridocyclitis - Study eye  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Neovascular age-related macular degeneration - Fellow eye  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Posterior capsule opacification - Study eye  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Retinal artery occlusion - Study eye  1  2/356 (0.56%)  0/179 (0.00%)  2/535 (0.37%) 
Retinal haemorrhage - Study eye  1  1/356 (0.28%)  1/179 (0.56%)  2/535 (0.37%) 
Retinal vasculitis - Study eye  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Retinal vein occlusion - Study eye  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Uveitis - Study eye  1  4/356 (1.12%)  0/179 (0.00%)  4/535 (0.75%) 
Visual acuity reduced - Study eye  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Vitreal cells - Study eye  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Vitreous haze - Study eye  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Vitritis - Study eye  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Gastrointestinal disorders       
Abdominal hernia  1  1/356 (0.28%)  1/179 (0.56%)  2/535 (0.37%) 
Constipation  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Diarrhoea  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Dysphagia  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Gastric ulcer  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Gastrointestinal ulcer  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Hiatus hernia  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Impaired gastric emptying  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Intestinal obstruction  1  1/356 (0.28%)  1/179 (0.56%)  2/535 (0.37%) 
Peptic ulcer haemorrhage  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Small intestinal obstruction  1  1/356 (0.28%)  1/179 (0.56%)  2/535 (0.37%) 
Upper gastrointestinal haemorrhage  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
General disorders       
Chest pain  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Drowning  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Pyrexia  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Systemic inflammatory response syndrome  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Hepatobiliary disorders       
Hepatic cyst  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Infections and infestations       
Anal abscess  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Bronchitis  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
COVID-19  1  2/356 (0.56%)  1/179 (0.56%)  3/535 (0.56%) 
COVID-19 pneumonia  1  2/356 (0.56%)  1/179 (0.56%)  3/535 (0.56%) 
Clostridium difficile colitis  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Diverticulitis  1  1/356 (0.28%)  1/179 (0.56%)  2/535 (0.37%) 
Endophthalmitis - Study eye  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Infective exacerbation of bronchiectasis  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Influenza  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Pneumonia  1  5/356 (1.40%)  1/179 (0.56%)  6/535 (1.12%) 
Pneumonia aspiration  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Postoperative wound infection  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Sepsis  1  2/356 (0.56%)  0/179 (0.00%)  2/535 (0.37%) 
Septic shock  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Urinary tract infection  1  2/356 (0.56%)  0/179 (0.00%)  2/535 (0.37%) 
Urosepsis  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Injury, poisoning and procedural complications       
Corneal abrasion - Study eye  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Face injury  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Femur fracture  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Foot fracture  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Hip fracture  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
Pelvic fracture  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Postoperative respiratory failure  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Rib fracture  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Road traffic accident  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Upper limb fracture  1  1/356 (0.28%)  1/179 (0.56%)  2/535 (0.37%) 
Wrist fracture  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Investigations       
Streptococcus test positive - Study eye  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Metabolism and nutrition disorders       
Dehydration  1  2/356 (0.56%)  0/179 (0.00%)  2/535 (0.37%) 
Hypoglycaemia  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Hyponatraemia  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Musculoskeletal and connective tissue disorders       
Intervertebral disc degeneration  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Lumbar spinal stenosis  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Osteoarthritis  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Pathological fracture  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma of colon  1  1/356 (0.28%)  1/179 (0.56%)  2/535 (0.37%) 
Bone cancer  1  1/356 (0.28%)  1/179 (0.56%)  2/535 (0.37%) 
Breast cancer  1  2/356 (0.56%)  0/179 (0.00%)  2/535 (0.37%) 
Choroid neoplasm - Fellow eye  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Hepatic cancer  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Lung adenocarcinoma  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Lung cancer metastatic  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Lung neoplasm malignant  1  3/356 (0.84%)  0/179 (0.00%)  3/535 (0.56%) 
Malignant peritoneal neoplasm  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Non-small cell lung cancer metastatic  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Oropharyngeal squamous cell carcinoma  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Prostate cancer  1  1/356 (0.28%)  2/179 (1.12%)  3/535 (0.56%) 
Renal cancer metastatic  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Squamous cell carcinoma  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Nervous system disorders       
Cerebral haemorrhage  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Cerebral infarction  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Cerebrovascular accident  1  1/356 (0.28%)  1/179 (0.56%)  2/535 (0.37%) 
Haemorrhagic cerebral infarction  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Intracranial aneurysm  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Loss of consciousness  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Migraine  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Presyncope  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Seizure  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Syncope  1  2/356 (0.56%)  2/179 (1.12%)  4/535 (0.75%) 
Transient ischaemic attack  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
Renal and urinary disorders       
Acute kidney injury  1  2/356 (0.56%)  1/179 (0.56%)  3/535 (0.56%) 
Haematuria  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Nephrolithiasis  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure  1  1/356 (0.28%)  1/179 (0.56%)  2/535 (0.37%) 
Asphyxia  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Chronic obstructive pulmonary disease  1  2/356 (0.56%)  0/179 (0.00%)  2/535 (0.37%) 
Dyspnoea  1  1/356 (0.28%)  1/179 (0.56%)  2/535 (0.37%) 
Haemoptysis  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Pleural effusion  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Pleuritic pain  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Pulmonary embolism  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Pulmonary hypertension  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Pulmonary mass  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Respiratory failure  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Skin and subcutaneous tissue disorders       
Skin ulcer  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Stasis dermatitis  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Vascular disorders       
Aortic stenosis  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Hypotension  1  1/356 (0.28%)  0/179 (0.00%)  1/535 (0.19%) 
Peripheral arterial occlusive disease  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
Shock  1  0/356 (0.00%)  1/179 (0.56%)  1/535 (0.19%) 
1
Term from vocabulary, MedDRA (24.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Brolucizumab 6mg Aflibercept 2mg Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   287/356 (80.62%)   149/179 (83.24%)   436/535 (81.50%) 
Blood and lymphatic system disorders       
Anaemia  1  4/356 (1.12%)  6/179 (3.35%)  10/535 (1.87%) 
Cardiac disorders       
Arrhythmia  1  1/356 (0.28%)  2/179 (1.12%)  3/535 (0.56%) 
Arteriosclerosis coronary artery  1  1/356 (0.28%)  2/179 (1.12%)  3/535 (0.56%) 
Atrial fibrillation  1  9/356 (2.53%)  10/179 (5.59%)  19/535 (3.55%) 
Tachycardia  1  4/356 (1.12%)  0/179 (0.00%)  4/535 (0.75%) 
Ear and labyrinth disorders       
Ear pain  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
Vertigo  1  8/356 (2.25%)  1/179 (0.56%)  9/535 (1.68%) 
Endocrine disorders       
Hypothyroidism  1  5/356 (1.40%)  3/179 (1.68%)  8/535 (1.50%) 
Eye disorders       
Blepharitis - Fellow eye  1  10/356 (2.81%)  4/179 (2.23%)  14/535 (2.62%) 
Blepharitis - Study eye  1  13/356 (3.65%)  5/179 (2.79%)  18/535 (3.36%) 
Cataract - Fellow eye  1  13/356 (3.65%)  3/179 (1.68%)  16/535 (2.99%) 
Cataract - Study eye  1  23/356 (6.46%)  4/179 (2.23%)  27/535 (5.05%) 
Cataract nuclear - Fellow eye  1  4/356 (1.12%)  1/179 (0.56%)  5/535 (0.93%) 
Cataract nuclear - Study eye  1  8/356 (2.25%)  1/179 (0.56%)  9/535 (1.68%) 
Cataract subcapsular - Study eye  1  16/356 (4.49%)  6/179 (3.35%)  22/535 (4.11%) 
Chalazion - Study eye  1  4/356 (1.12%)  2/179 (1.12%)  6/535 (1.12%) 
Conjunctival haemorrhage - Fellow eye  1  6/356 (1.69%)  7/179 (3.91%)  13/535 (2.43%) 
Conjunctival haemorrhage - Study eye  1  32/356 (8.99%)  14/179 (7.82%)  46/535 (8.60%) 
Corneal disorder - Study eye  1  2/356 (0.56%)  2/179 (1.12%)  4/535 (0.75%) 
Corneal oedema - Study eye  1  3/356 (0.84%)  2/179 (1.12%)  5/535 (0.93%) 
Diabetic retinopathy - Study eye  1  2/356 (0.56%)  2/179 (1.12%)  4/535 (0.75%) 
Diplopia - Study eye  1  5/356 (1.40%)  1/179 (0.56%)  6/535 (1.12%) 
Dry age-related macular degeneration - Fellow eye  1  5/356 (1.40%)  0/179 (0.00%)  5/535 (0.93%) 
Dry age-related macular degeneration - Study eye  1  10/356 (2.81%)  4/179 (2.23%)  14/535 (2.62%) 
Dry eye - Fellow eye  1  10/356 (2.81%)  3/179 (1.68%)  13/535 (2.43%) 
Dry eye - Study eye  1  19/356 (5.34%)  4/179 (2.23%)  23/535 (4.30%) 
Eye irritation - Study eye  1  4/356 (1.12%)  0/179 (0.00%)  4/535 (0.75%) 
Eye pain - Study eye  1  9/356 (2.53%)  4/179 (2.23%)  13/535 (2.43%) 
Iridocyclitis - Fellow eye  1  1/356 (0.28%)  2/179 (1.12%)  3/535 (0.56%) 
Iridocyclitis - Study eye  1  17/356 (4.78%)  3/179 (1.68%)  20/535 (3.74%) 
Iritis - Study eye  1  6/356 (1.69%)  2/179 (1.12%)  8/535 (1.50%) 
Lacrimation increased - Study eye  1  4/356 (1.12%)  2/179 (1.12%)  6/535 (1.12%) 
Meibomian gland dysfunction - Study eye  1  1/356 (0.28%)  2/179 (1.12%)  3/535 (0.56%) 
Neovascular age-related macular degeneration - Fellow eye  1  19/356 (5.34%)  13/179 (7.26%)  32/535 (5.98%) 
Neovascular age-related macular degeneration - Study eye  1  9/356 (2.53%)  5/179 (2.79%)  14/535 (2.62%) 
Ocular hypertension - Fellow eye  1  1/356 (0.28%)  2/179 (1.12%)  3/535 (0.56%) 
Ocular hypertension - Study eye  1  3/356 (0.84%)  2/179 (1.12%)  5/535 (0.93%) 
Optic disc haemorrhage - Study eye  1  2/356 (0.56%)  2/179 (1.12%)  4/535 (0.75%) 
Posterior capsule opacification - Fellow eye  1  9/356 (2.53%)  4/179 (2.23%)  13/535 (2.43%) 
Posterior capsule opacification - Study eye  1  8/356 (2.25%)  8/179 (4.47%)  16/535 (2.99%) 
Punctate keratitis - Fellow eye  1  7/356 (1.97%)  2/179 (1.12%)  9/535 (1.68%) 
Punctate keratitis - Study eye  1  9/356 (2.53%)  5/179 (2.79%)  14/535 (2.62%) 
Retinal artery embolism - Study eye  1  4/356 (1.12%)  0/179 (0.00%)  4/535 (0.75%) 
Retinal haemorrhage - Fellow eye  1  9/356 (2.53%)  6/179 (3.35%)  15/535 (2.80%) 
Retinal haemorrhage - Study eye  1  16/356 (4.49%)  5/179 (2.79%)  21/535 (3.93%) 
Subretinal fluid - Fellow eye  1  4/356 (1.12%)  2/179 (1.12%)  6/535 (1.12%) 
Subretinal fluid - Study eye  1  3/356 (0.84%)  2/179 (1.12%)  5/535 (0.93%) 
Uveitis - Study eye  1  8/356 (2.25%)  3/179 (1.68%)  11/535 (2.06%) 
Vision blurred - Study eye  1  7/356 (1.97%)  1/179 (0.56%)  8/535 (1.50%) 
Visual acuity reduced - Fellow eye  1  4/356 (1.12%)  0/179 (0.00%)  4/535 (0.75%) 
Visual acuity reduced - Study eye  1  22/356 (6.18%)  6/179 (3.35%)  28/535 (5.23%) 
Vitreal cells - Study eye  1  3/356 (0.84%)  4/179 (2.23%)  7/535 (1.31%) 
Vitreous detachment - Fellow eye  1  6/356 (1.69%)  3/179 (1.68%)  9/535 (1.68%) 
Vitreous detachment - Study eye  1  18/356 (5.06%)  5/179 (2.79%)  23/535 (4.30%) 
Vitreous floaters - Fellow eye  1  4/356 (1.12%)  2/179 (1.12%)  6/535 (1.12%) 
Vitreous floaters - Study eye  1  21/356 (5.90%)  10/179 (5.59%)  31/535 (5.79%) 
Vitreous haemorrhage - Study eye  1  6/356 (1.69%)  2/179 (1.12%)  8/535 (1.50%) 
Vitritis - Study eye  1  9/356 (2.53%)  3/179 (1.68%)  12/535 (2.24%) 
Gastrointestinal disorders       
Constipation  1  3/356 (0.84%)  2/179 (1.12%)  5/535 (0.93%) 
Dental caries  1  9/356 (2.53%)  1/179 (0.56%)  10/535 (1.87%) 
Diarrhoea  1  6/356 (1.69%)  4/179 (2.23%)  10/535 (1.87%) 
Dyspepsia  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
Food poisoning  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
Gastrooesophageal reflux disease  1  6/356 (1.69%)  4/179 (2.23%)  10/535 (1.87%) 
Hiatus hernia  1  3/356 (0.84%)  3/179 (1.68%)  6/535 (1.12%) 
Large intestine polyp  1  0/356 (0.00%)  3/179 (1.68%)  3/535 (0.56%) 
Nausea  1  6/356 (1.69%)  3/179 (1.68%)  9/535 (1.68%) 
Toothache  1  2/356 (0.56%)  3/179 (1.68%)  5/535 (0.93%) 
General disorders       
Fatigue  1  4/356 (1.12%)  0/179 (0.00%)  4/535 (0.75%) 
Oedema peripheral  1  9/356 (2.53%)  6/179 (3.35%)  15/535 (2.80%) 
Immune system disorders       
Drug hypersensitivity  1  1/356 (0.28%)  2/179 (1.12%)  3/535 (0.56%) 
Seasonal allergy  1  12/356 (3.37%)  8/179 (4.47%)  20/535 (3.74%) 
Infections and infestations       
Bronchitis  1  15/356 (4.21%)  8/179 (4.47%)  23/535 (4.30%) 
COVID-19  1  8/356 (2.25%)  7/179 (3.91%)  15/535 (2.80%) 
Cellulitis  1  4/356 (1.12%)  2/179 (1.12%)  6/535 (1.12%) 
Chorioretinitis - Study eye  1  9/356 (2.53%)  1/179 (0.56%)  10/535 (1.87%) 
Conjunctivitis - Study eye  1  4/356 (1.12%)  0/179 (0.00%)  4/535 (0.75%) 
Cystitis  1  2/356 (0.56%)  3/179 (1.68%)  5/535 (0.93%) 
Diverticulitis  1  2/356 (0.56%)  3/179 (1.68%)  5/535 (0.93%) 
Ear infection  1  4/356 (1.12%)  3/179 (1.68%)  7/535 (1.31%) 
Fungal infection  1  4/356 (1.12%)  3/179 (1.68%)  7/535 (1.31%) 
Gastroenteritis viral  1  2/356 (0.56%)  3/179 (1.68%)  5/535 (0.93%) 
Herpes zoster  1  2/356 (0.56%)  2/179 (1.12%)  4/535 (0.75%) 
Hordeolum - Fellow eye  1  5/356 (1.40%)  3/179 (1.68%)  8/535 (1.50%) 
Hordeolum - Study eye  1  4/356 (1.12%)  2/179 (1.12%)  6/535 (1.12%) 
Influenza  1  7/356 (1.97%)  2/179 (1.12%)  9/535 (1.68%) 
Localised infection  1  4/356 (1.12%)  1/179 (0.56%)  5/535 (0.93%) 
Nasopharyngitis  1  12/356 (3.37%)  10/179 (5.59%)  22/535 (4.11%) 
Pharyngitis  1  1/356 (0.28%)  2/179 (1.12%)  3/535 (0.56%) 
Pneumonia  1  9/356 (2.53%)  1/179 (0.56%)  10/535 (1.87%) 
Sinusitis  1  11/356 (3.09%)  11/179 (6.15%)  22/535 (4.11%) 
Tooth abscess  1  4/356 (1.12%)  1/179 (0.56%)  5/535 (0.93%) 
Tooth infection  1  4/356 (1.12%)  1/179 (0.56%)  5/535 (0.93%) 
Upper respiratory tract infection  1  17/356 (4.78%)  6/179 (3.35%)  23/535 (4.30%) 
Urinary tract infection  1  36/356 (10.11%)  16/179 (8.94%)  52/535 (9.72%) 
Injury, poisoning and procedural complications       
Arthropod bite  1  2/356 (0.56%)  2/179 (1.12%)  4/535 (0.75%) 
Bone contusion  1  1/356 (0.28%)  2/179 (1.12%)  3/535 (0.56%) 
Fall  1  23/356 (6.46%)  6/179 (3.35%)  29/535 (5.42%) 
Foreign body in eye - Study eye  1  11/356 (3.09%)  2/179 (1.12%)  13/535 (2.43%) 
Hand fracture  1  1/356 (0.28%)  2/179 (1.12%)  3/535 (0.56%) 
Ligament sprain  1  4/356 (1.12%)  3/179 (1.68%)  7/535 (1.31%) 
Meniscus injury  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
Muscle strain  1  5/356 (1.40%)  1/179 (0.56%)  6/535 (1.12%) 
Posterior capsule rupture - Study eye  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
Skin laceration  1  4/356 (1.12%)  1/179 (0.56%)  5/535 (0.93%) 
Investigations       
Amylase increased  1  1/356 (0.28%)  3/179 (1.68%)  4/535 (0.75%) 
Blood alkaline phosphatase increased  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
Blood cholesterol increased  1  3/356 (0.84%)  4/179 (2.23%)  7/535 (1.31%) 
Blood creatinine increased  1  3/356 (0.84%)  2/179 (1.12%)  5/535 (0.93%) 
Blood glucose increased  1  5/356 (1.40%)  1/179 (0.56%)  6/535 (1.12%) 
Blood lactate dehydrogenase increased  1  3/356 (0.84%)  2/179 (1.12%)  5/535 (0.93%) 
Blood phosphorus increased  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
Blood potassium increased  1  2/356 (0.56%)  2/179 (1.12%)  4/535 (0.75%) 
Blood pressure increased  1  6/356 (1.69%)  3/179 (1.68%)  9/535 (1.68%) 
Blood triglycerides increased  1  4/356 (1.12%)  2/179 (1.12%)  6/535 (1.12%) 
Blood urea increased  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
Intraocular pressure increased - Fellow eye  1  2/356 (0.56%)  2/179 (1.12%)  4/535 (0.75%) 
Intraocular pressure increased - Study eye  1  19/356 (5.34%)  7/179 (3.91%)  26/535 (4.86%) 
Lipase increased  1  2/356 (0.56%)  2/179 (1.12%)  4/535 (0.75%) 
Mean cell volume increased  1  1/356 (0.28%)  2/179 (1.12%)  3/535 (0.56%) 
Monocyte count increased  1  2/356 (0.56%)  2/179 (1.12%)  4/535 (0.75%) 
Optic nerve cup/disc ratio increased - Study eye  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
Red blood cell count decreased  1  5/356 (1.40%)  1/179 (0.56%)  6/535 (1.12%) 
Urine analysis abnormal  1  4/356 (1.12%)  2/179 (1.12%)  6/535 (1.12%) 
White blood cell count increased  1  2/356 (0.56%)  2/179 (1.12%)  4/535 (0.75%) 
Metabolism and nutrition disorders       
Dehydration  1  5/356 (1.40%)  0/179 (0.00%)  5/535 (0.93%) 
Hypercalcaemia  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
Hypercholesterolaemia  1  6/356 (1.69%)  4/179 (2.23%)  10/535 (1.87%) 
Hyperlipidaemia  1  6/356 (1.69%)  1/179 (0.56%)  7/535 (1.31%) 
Hypertriglyceridaemia  1  0/356 (0.00%)  3/179 (1.68%)  3/535 (0.56%) 
Hyponatraemia  1  4/356 (1.12%)  0/179 (0.00%)  4/535 (0.75%) 
Type 2 diabetes mellitus  1  4/356 (1.12%)  3/179 (1.68%)  7/535 (1.31%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  15/356 (4.21%)  6/179 (3.35%)  21/535 (3.93%) 
Arthritis  1  4/356 (1.12%)  3/179 (1.68%)  7/535 (1.31%) 
Back pain  1  13/356 (3.65%)  3/179 (1.68%)  16/535 (2.99%) 
Dupuytren's contracture  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
Intervertebral disc degeneration  1  1/356 (0.28%)  2/179 (1.12%)  3/535 (0.56%) 
Muscle spasms  1  4/356 (1.12%)  4/179 (2.23%)  8/535 (1.50%) 
Osteoarthritis  1  11/356 (3.09%)  3/179 (1.68%)  14/535 (2.62%) 
Osteoporosis  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
Pain in extremity  1  2/356 (0.56%)  4/179 (2.23%)  6/535 (1.12%) 
Rheumatoid arthritis  1  3/356 (0.84%)  3/179 (1.68%)  6/535 (1.12%) 
Rotator cuff syndrome  1  0/356 (0.00%)  3/179 (1.68%)  3/535 (0.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  7/356 (1.97%)  0/179 (0.00%)  7/535 (1.31%) 
Squamous cell carcinoma  1  5/356 (1.40%)  2/179 (1.12%)  7/535 (1.31%) 
Squamous cell carcinoma of skin  1  4/356 (1.12%)  0/179 (0.00%)  4/535 (0.75%) 
Nervous system disorders       
Amnesia  1  2/356 (0.56%)  2/179 (1.12%)  4/535 (0.75%) 
Carotid artery stenosis  1  4/356 (1.12%)  1/179 (0.56%)  5/535 (0.93%) 
Dizziness  1  2/356 (0.56%)  2/179 (1.12%)  4/535 (0.75%) 
Headache  1  6/356 (1.69%)  7/179 (3.91%)  13/535 (2.43%) 
Nerve compression  1  1/356 (0.28%)  2/179 (1.12%)  3/535 (0.56%) 
Neuropathy peripheral  1  2/356 (0.56%)  2/179 (1.12%)  4/535 (0.75%) 
Sciatica  1  2/356 (0.56%)  3/179 (1.68%)  5/535 (0.93%) 
Psychiatric disorders       
Anxiety  1  5/356 (1.40%)  4/179 (2.23%)  9/535 (1.68%) 
Depression  1  4/356 (1.12%)  3/179 (1.68%)  7/535 (1.31%) 
Insomnia  1  4/356 (1.12%)  1/179 (0.56%)  5/535 (0.93%) 
Renal and urinary disorders       
Acute kidney injury  1  4/356 (1.12%)  2/179 (1.12%)  6/535 (1.12%) 
Haematuria  1  7/356 (1.97%)  1/179 (0.56%)  8/535 (1.50%) 
Nephrolithiasis  1  3/356 (0.84%)  3/179 (1.68%)  6/535 (1.12%) 
Proteinuria  1  12/356 (3.37%)  5/179 (2.79%)  17/535 (3.18%) 
Reproductive system and breast disorders       
Prostatomegaly  1  3/356 (0.84%)  2/179 (1.12%)  5/535 (0.93%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  2/356 (0.56%)  2/179 (1.12%)  4/535 (0.75%) 
Chronic obstructive pulmonary disease  1  7/356 (1.97%)  2/179 (1.12%)  9/535 (1.68%) 
Cough  1  11/356 (3.09%)  5/179 (2.79%)  16/535 (2.99%) 
Dyspnoea  1  4/356 (1.12%)  2/179 (1.12%)  6/535 (1.12%) 
Pulmonary mass  1  5/356 (1.40%)  0/179 (0.00%)  5/535 (0.93%) 
Skin and subcutaneous tissue disorders       
Decubitus ulcer  1  1/356 (0.28%)  2/179 (1.12%)  3/535 (0.56%) 
Psoriasis  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
Rash  1  3/356 (0.84%)  7/179 (3.91%)  10/535 (1.87%) 
Urticaria  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
Vascular disorders       
Arteriosclerosis  1  2/356 (0.56%)  3/179 (1.68%)  5/535 (0.93%) 
Deep vein thrombosis  1  0/356 (0.00%)  2/179 (1.12%)  2/535 (0.37%) 
Hypertension  1  28/356 (7.87%)  23/179 (12.85%)  51/535 (9.53%) 
Hypotension  1  3/356 (0.84%)  3/179 (1.68%)  6/535 (1.12%) 
Peripheral arterial occlusive disease  1  2/356 (0.56%)  2/179 (1.12%)  4/535 (0.75%) 
1
Term from vocabulary, MedDRA (24.1)
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: + 1 862 778 8300
EMail: Novartis.email@Novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT03710564    
Other Study ID Numbers: CRTH258AUS04
First Submitted: October 16, 2018
First Posted: October 18, 2018
Results First Submitted: June 28, 2022
Results First Posted: July 22, 2022
Last Update Posted: July 22, 2022