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

• ClinicalTrials.gov Identifier: NCT03823300
• Recruitment Status: Completed
• First Posted: January 30, 2019
• Results First Posted: May 4, 2022
• Last Update Posted: January 13, 2023
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief Summary:

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).

Condition or disease	Intervention/treatment	Phase
Wet Macular Degeneration	Drug: Faricimab; Drug: Aflibercept; Procedure: Sham Procedure	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 658 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (LUCERNE)
• Actual Study Start Date: March 11, 2019
• Actual Primary Completion Date: October 5, 2020
• Actual Study Completion Date: January 7, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm A: Faricimab	Drug: Faricimab; Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.; Other Names: VABYSMO™; RO6867461; RG7716; Procedure: Sham Procedure; The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatment arms at applicable visits to maintain masking.
Active Comparator: Arm B: Aflibercept	Drug: Aflibercept; Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W).; Other Name: Eylea; Procedure: Sham Procedure; The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatment arms at applicable visits to maintain masking.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 [ Time Frame: From Baseline through Week 48 ]
   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.

Secondary Outcome Measures :

1. Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60 [ Time Frame: From Baseline through Week 60 ]
   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.
2. Change From Baseline in BCVA in the Study Eye Over Time [ 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 ]
   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.
3. 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 [ Time Frame: Baseline, average of Weeks 40, 44, and 48 ]
   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) weights 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. 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.
4. Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60 [ Time Frame: Baseline, average of Weeks 52, 56, and 60 ]
   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) weights 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. 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.
5. Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time [ 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 ]
   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) weights 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. 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.
6. Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time [ 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 ]
   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) weights 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. 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.
7. Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time [ 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 ]
   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) weights 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. 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.
8. Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time [ 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 ]
   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) weights 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. 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.
9. 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 [ Time Frame: Baseline, average of Weeks 40, 44, and 48 ]
   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) weights 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. 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.
10. Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60 [ Time Frame: Baseline, average of Weeks 52, 56, and 60 ]
    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) weights 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. 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.
11. Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time [ 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 ]
    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 avoiding a loss of letters in BCVA from baseline was based on the Cochran-Mantel Haenszel (CMH) weights 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. 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.
12. Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time [ 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 ]
    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 avoiding a loss of letters in BCVA from baseline was based on the Cochran-Mantel Haenszel (CMH) weights 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. 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.
13. Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time [ 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 ]
    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 avoiding a loss of letters in BCVA from baseline was based on the Cochran-Mantel Haenszel (CMH) weights 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. 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.
14. 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 [ Time Frame: Baseline, average of Weeks 40, 44, and 48 ]
    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) weights 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. 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.
15. 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 [ 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 ]
    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) weights 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. 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.
16. 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 [ Time Frame: Baseline, average of Weeks 40, 44, and 48 ]
    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) weights stratified by baseline BCVA (<69 letters vs. ≥69 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. 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.
17. Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time [ 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 ]
    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) weights stratified by baseline BCVA (<69 letters vs. ≥69 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. 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.
18. 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 [ Time Frame: Baseline, average of Weeks 40, 44, and 48 ]
    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) weights 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. 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.
19. Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time [ 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 ]
    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) weights 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. 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.
20. Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48 [ Time Frame: Week 48 ]
    Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 48. The treatment interval at a given visit is defined as the treatment interval decision followed at that visit. The 95% confidence interval (CI) is a rounding of 95.03% CI.
21. Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60 [ Time Frame: Week 60 ]
    Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 60. The treatment interval at a given visit is defined as the treatment interval decision followed at that visit. The 95% confidence interval (CI) is a rounding of 95.03% CI.
22. Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112 [ Time Frame: Weeks 108 and 112 ]
    Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 112. Treatment interval at a given visit is defined as the treatment interval decision followed at that visit. Treatment interval at Week 112 is calculated using data recorded at Week 108. The 95% confidence interval (CI) is a rounding of 95.03% CI.
23. Number of Study Drug Injections Received in the Study Eye Through Week 48 [ Time Frame: From Baseline through Week 48 ]
24. Number of Study Drug Injections Received in the Study Eye Through Week 60 [ Time Frame: From Baseline through Week 60 ]
25. Number of Study Drug Injections Received in the Study Eye Through Week 108 [ Time Frame: From Baseline through Week 108 ]
26. Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48 [ Time Frame: From Baseline through Week 48 ]
    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.
27. Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60 [ Time Frame: From Baseline through Week 60 ]
    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.
28. Change From Baseline in Central Subfield Thickness in the Study Eye Over Time [ 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 ]
    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.
29. Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112 ]
    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) weights 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. 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.
30. Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112 ]
    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 subretinal fluid were based on the Cochran-Mantel Haenszel (CMH) weights 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. 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.
31. Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112 ]
    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 and subretinal fluid were based on the Cochran-Mantel Haenszel (CMH) weights 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. 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.
32. Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112 ]
    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) weights 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. 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.
33. Percentage of Participants With Absence of Intraretinal Cysts in the Study Eye Over Time [ Time Frame: Up to 112 weeks ]
34. Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48 [ Time Frame: Baseline and Week 48 ]
    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.
35. Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 112 [ Time Frame: Baseline and Week 112 ]
    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.
36. Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 48 [ Time Frame: Baseline and Week 48 ]
    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.
37. Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 112 [ Time Frame: Baseline and Week 112 ]
    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.
38. Percentage of Participants With at Least One Adverse Event [ Time Frame: From first dose of study drug through end of study (up to 112 weeks) ]
    This analysis of adverse events (AEs) includes both ocular and non-ocular (systemic) AEs. Multiple occurrences of the same AE in one individual are counted only once. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. AEs of special interest included the following: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law; Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation (IOI).
39. Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye [ Time Frame: From first dose of study drug through end of study (up to 112 weeks) ]
    This analysis of adverse events (AEs) only includes ocular AEs, which are categorized as having occurred either in the study eye or the fellow eye. Multiple occurrences of the same AE in one individual are counted only once. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. Ocular AEs of special interest included the following: Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation (IOI).
40. Percentage of Participants With at Least One Non-Ocular Adverse Event [ Time Frame: From first dose of study drug through end of study (up to 112 weeks) ]
    This analysis of adverse events (AEs) only includes non-ocular (systemic) AEs. Multiple occurrences of the same AE in one individual are counted only once. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. The non-ocular AE of special interest was: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.
41. Plasma Concentration of Faricimab Over Time [ Time Frame: Pre-dose at Baseline, Weeks 4, 16, 20, 48, 76, and 112 ]
    Faricimab concentration in plasma was determined using a validated immunoassay method.
42. Percentage of Participants Who Tested Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study [ Time Frame: Pre-dose at Baseline, Weeks 4, 20, 48, 76, and 112 ]
    Anti-drug antibodies (ADAs) against fariciamb were detected in plasma using a validated bridging enzyme-linked immunosorbent assay (ELISA). The percentage of participants with treatment-emergent ADA-positive samples includes post-baseline evaluable participants with at least one treatment-induced (defined as having an ADA-negative sample or missing sample at baseline and any positive post-baseline sample) or treatment-boosted (defined as having an ADA-positive sample at baseline and any positive post-baseline sample with a titer that is equal to or greater than 4-fold baseline titer) ADA-positive sample during the study treatment period.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye
• Ability to comply with the study protocol, in the investigator's judgment
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate <1% per year during the treatment period and for at least 3 months after the final dose of study treatment
• Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

• Uncontrolled blood pressure, defined as systolic blood pressure >180 millimeters of mercury (mmHg) and/or diastolic blood pressure >100 mmHg while a patient is at rest on Day 1
• Pregnancy or breastfeeding, or intention to become pregnant during the study
• CNV due to causes other than AMD in the study eye
• Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
• Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
• Uncontrolled glaucoma in the study eye
• Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye
• Prior IVT administration of faricimab in either eye
• History of idiopathic or autoimmune-associated uveitis in either eye
• Active ocular inflammation or suspected or active ocular or periocular infection in either eye
• Other protocol-specified exclusion criteria may apply

Contacts and Locations

Locations

United States, Arizona

Associated Retina Consultants

Phoenix, Arizona, United States, 85020

Arizona Retina and Vitreous Consultants

Phoenix, Arizona, United States, 85021

United States, California

Northern California Retina Vitreous Associates

Mountain View, California, United States, 94040

Retinal Consultants Med Group

Sacramento, California, United States, 95825

Orange County Retina Med Group

Santa Ana, California, United States, 92705

California Retina Consultants

Santa Barbara, California, United States, 93103

United States, Colorado

Colorado Retina Associates, PC

Lakewood, Colorado, United States, 80228

United States, Florida

Retina Group of Florida

Fort Lauderdale, Florida, United States, 33308

Retina Care Specialists

Palm Beach Gardens, Florida, United States, 33410

Southern Vitreoretinal Assoc

Tallahassee, Florida, United States, 32308

Retina Associates of Florida, LLC

Tampa, Florida, United States, 33609

United States, Georgia

Southeast Retina Center

Augusta, Georgia, United States, 30909

Georgia Retina PC

Marietta, Georgia, United States, 30060-1137

United States, Hawaii

Retina Consultants of Hawaii

'Aiea, Hawaii, United States, 96701

United States, Illinois

University Retina and Macula Associates, PC

Oak Forest, Illinois, United States, 60452

Prairie Retina Center

Springfield, Illinois, United States, 62704

United States, Indiana

Raj K. Maturi, MD PC

Indianapolis, Indiana, United States, 46290

United States, Iowa

Wolfe Eye Clinic

West Des Moines, Iowa, United States, 50266

United States, Maine

Maine Eye Center

Portland, Maine, United States, 04101

United States, Maryland

The Retina Care Center

Baltimore, Maryland, United States, 21209

Cumberland Valley Retina PC

Hagerstown, Maryland, United States, 21740

Retina Specialists

Towson, Maryland, United States, 21204

United States, Massachusetts

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States, 02114

United States, Minnesota

VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

Edina, Minnesota, United States, 55435

United States, New York

Island Retina

Shirley, New York, United States, 11967

United States, Ohio

Retina Assoc of Cleveland Inc

Cleveland, Ohio, United States, 44122

The Ohio State University Havener Eye Institute

Columbus, Ohio, United States, 43212

Midwest Retina

Dublin, Ohio, United States, 43016

United States, Pennsylvania

Mid Atlantic Retina - Wills Eye Hospital

Philadelphia, Pennsylvania, United States, 19107

United States, South Carolina

Palmetto Retina Center

West Columbia, South Carolina, United States, 29169

United States, Tennessee

Southeastern Retina Associates Chattanooga

Chattanooga, Tennessee, United States, 37421

United States, Texas

Retina Res Institute of Texas

Abilene, Texas, United States, 79606

Austin Retina Associates

Austin, Texas, United States, 78705-1169

Austin Clinical Research LLC

Austin, Texas, United States, 78750

Retina Specialists

DeSoto, Texas, United States, 75115

Retina Center of Texas

Southlake, Texas, United States, 76092

Retina Consultants of Houston

The Woodlands, Texas, United States, 77384

Strategic Clinical Research Group, LLC

Willow Park, Texas, United States, 76087

United States, Utah

Retina Associates of Utah

Salt Lake City, Utah, United States, 84107

United States, Virginia

Piedmont Eye Center

Lynchburg, Virginia, United States, 24502

Wagner Macula & Retina Center

Norfolk, Virginia, United States, 23502

United States, Washington

Retina Center Northwest

Silverdale, Washington, United States, 98383

Argentina

Fundacion Zambrano

Caba, Argentina, C1017AAO

Centro Oftalmológico Dr. Charles S.A.

Capital Federal, Argentina, C1015ABO

Oftalmos

Capital Federal, Argentina, C1120AAN

Buenos Aires Mácula

Ciudad Autonoma Buenos Aires, Argentina, C1061AAE

Oftar

Mendoza, Argentina, M5500GGK

Grupo Laser Vision

Rosario, Argentina, S2000DLA

Organizacion Medica de Investigacion

San Nicolás, Argentina, C1015ABO

Australia, New South Wales

Eyeclinic Albury Wodonga

Albury, New South Wales, Australia, 2640

Marsden Eye Research Centre

Parramatta, New South Wales, Australia, 2150

Strathfield Retina Clinic

Strathfield, New South Wales, Australia, 2135

Sydney Eye Hospital

Sydney, New South Wales, Australia, 2000

Sydney Retina Clinic and Day Surgery

Sydney, New South Wales, Australia, 2000

Sydney West Retina

Westmead, New South Wales, Australia, 2145

Australia, Victoria

Centre For Eye Research Australia

East Melbourne, Victoria, Australia, 3002

Retina Specialists Victoria

Rowville, Victoria, Australia, 3178

Australia, Western Australia

The Lions Eye Institute

Nedlands, Western Australia, Australia, 6009

Austria

LKH-Univ.Klinikum Graz; Universitäts-Augenklinik

Graz, Austria, 8036

Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

Wien, Austria, 1090

Brazil

Hospital de Olhos de Aparecida - HOA

Aparecida de Goiania, GO, Brazil, 74980-010

Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

Sao Paulo, SP, Brazil, 04023-062

Bulgaria

Pentagram Eye Hospital (Medical Center "Pentagram")

Sofia, Bulgaria, 1309

Specialized Hospital for Active Treatment of Eye Diseases Zora

Sofia, Bulgaria, 1784

China

Peking Union Medical College Hospital

Beijing City, China, 100032

Beijing Friendship Hospital

Beijing, China, 100050

Beijing Tongren Hospital

Beijing, China, 100730

The Second Hospital of Jilin University; ophthalmology department

Changchun City, China, 130041

West China Hospital, Sichuan University

Chengdu, China, 610041

Southwest Hospital , Third Military Medical University; Ophthalmology

Chongqing City, China, 400014

Daping Hospital of Third Military Medical University

Chongqing, China, 400042

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou City, China, 510060

The Second Affiliated Hospital of Harbin Medical University; ophthalmology department

Harbin, China, 150081

The Affiliated Eye Hospital of Nanjing Medical University

Nanjing City, China, 210029

Shanghai First People's Hospital

Shanghai, China, 200080

He Eye Specialist Shenyang Hospital

Shenyang City, China, 110034

Tianjin Eye Hospital

Tianjin City, China, 300050

Eye Hospital, Wenzhou Medical University

Wenzhou City, China, 325027

Wuxi No.2 People's Hospital

Wuxi, China, 214000

Denmark

Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning

Glostrup, Denmark, 2600

Sjællands Universitetshospital, Roskilde; Øjenafdelingen

Roskilde, Denmark, 4000

France

Chi De Creteil; Ophtalmologie

Creteil, France, 94010

Pole Vision Val d'Ouest; Ophtalmologie

Ecully, France, 69130

Hopital de la croix rousse; Ophtalmologie

Lyon cedex, France, 69317

Centre Paradis Monticelli; Ophtalmologie

Marseille, France, 13008

CHU Nantes - Hôtel Dieu; Ophthalmology

Nantes, France, 44093

Centre Odeon; Exploration Ophtalmologique

Paris, France, 75006

Hopital Lariboisiere; Ophtalmologie

Paris, France, 75010

Centre Ophtalmologique; Imagerie et laser

Paris, France, 75015

Centres Ophtalmologique St Exupéry; Ophtalmologie

St Cyr Sur Loire, France, 37540

Germany

Universitätkslinikum Düsseldorf, Augenklinik; Klinik fürAugenheilkunde

Düsseldorf, Germany, 40225

Universitätsklinikum Köln; Augenklinik

Köln, Germany, 50937

Augenabteilung am St. Franziskus-Hospital

Münster, Germany, 48145

Universitätsklinikum Münster; Augenheilkunde

Münster, Germany, 48149

Hong Kong

Queen Mary Hospital; Department of Ophthalmology

Hong Kong, Hong Kong

Hong Kong Eye Hospital; CUHK Eye Centre

Mongkok, Hong Kong

Hungary

Magyar Honvedseg Egeszsegugyi Kozpont; Szemészeti Osztály

Budapest, Hungary, 1068

Bajcsy-Zsilinszky Hospital

Budapest, Hungary, 1106

Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

Szeged, Hungary, 6720

Italy

Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

Roma, Lazio, Italy, 00133

UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

Genova, Liguria, Italy, 16132

ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

Milano, Lombardia, Italy, 20157

Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

Firenze, Toscana, Italy, 50134

Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria

Pisa, Toscana, Italy, 56124

A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica

Udine, Veneto, Italy, 33100

Korea, Republic of

Pusan National University Hospital

Busan, Korea, Republic of, 602-739

Yeungnam University Medical Center

Daegu, Korea, Republic of, 42415

Seoul National University Bundang Hospital

Seongnam-si, Korea, Republic of, 13620

Kyung Hee University Hospital

Seoul, Korea, Republic of, 02447

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Nune Eye Hospital; Ophthalmology

Seoul, Korea, Republic of, 06192

Samsung Medical Center

Seoul, Korea, Republic of, 135-710

Asan Medical Center.

Seoul, Korea, Republic of, 5505

Poland

OFTALMIKA Sp. z o.o

Bydgoszcz, Poland, 85-631

Optimum Profesorskie Centrum Okulistyki

Gdańsk, Poland, 80-809

SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

Krakow, Poland, 31-501

Caminomed

Tarnowskie Góry, Poland, 42-600

Portugal

Hospital de Braga; Servico de Oftalmologia

Braga, Portugal, 4710-243

Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia

Coimbra, Portugal, 3000-075

Hospital de Sao Joao; Servico de Oftalmologia

Porto, Portugal, 4200-319

Russian Federation

Intersec Research and Technology Complex "Eye Microsurgery" n.a. S.N. Fyodorov; Cheboksary Branch

Cheboksary, Marij EL, Russian Federation, 428000

"Intersec. Research and Technology Complex "Eye Microsurgery" n a Fyodorov Irkutsk branch

Irkutsk, Russian Federation, 664033

"Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch

Novosibirsk, Russian Federation, 630096

1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology

Saint Petersburg, Russian Federation, 197022

Singapore

National University Hospital; Ophthalmology Department

Singapore, Singapore, 119074

Singapore Eye Research Institute

Singapore, Singapore, 168751

Spain

Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia

Oviedo, Asturias, Spain, 33012

Hospital Universitario de Bellvitge

Hospitalet de Llobregat, Barcelona, Spain, 08907

Institut de la Macula i la retina

Barcelona, Spain, 08022

Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

Barcelona, Spain, 08028

Hospital Universitario Rio Hortega; Servicio de Oftalmologia

Valladolid, Spain, 47012

Hospital Universitario Miguel Servet; Servicio de Oftalmologia

Zaragoza, Spain, 50009

Taiwan

Changhua Christian Hospital; Department of Ophthalmology

Changhua, Taiwan, 500

Taipei Veterans General Hospital; Ophthalmology

Taipei, Taiwan, 11217

Chang Gung Medical Foundation - Linkou; Ophthalmology

Taoyuan, Taiwan, 333

Turkey

Hacettepe University Medical Faculty; Department of Ophthalmology

Ankara, Turkey, 06100

Ankara University Medical Faculty; Department of Ophthalmology

Ankara, Turkey, 06340

Gazi University Faculty of Medicine; Department Of Ophthalmology

Ankara, Turkey, 06560

Ege University Medical Faculty; Department of Ophthalmology

Izmir, Turkey, 35100

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Study Protocol  [PDF] August 6, 2019

Statistical Analysis Plan  [PDF] October 15, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Khanani AM, Guymer RH, Basu K, Boston H, Heier JS, Korobelnik JF, Kotecha A, Lin H, Silverman D, Swaminathan B, Willis JR, Yoon YH, Quezada-Ruiz C. TENAYA and LUCERNE: Rationale and Design for the Phase 3 Clinical Trials of Faricimab for Neovascular Age-Related Macular Degeneration. Ophthalmol Sci. 2021 Nov 17;1(4):100076. doi: 10.1016/j.xops.2021.100076. eCollection 2021 Dec.

Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, Figueroa MS, Lin H, Holz FG, Patel V, Lai TYY, Silverman D, Regillo C, Swaminathan B, Viola F, Cheung CMG, Wong TY; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Feb 19;399(10326):729-740. doi: 10.1016/S0140-6736(22)00010-1. Epub 2022 Jan 24.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT03823300
• Other Study ID Numbers: GR40844; 2018-004042-42 ( EudraCT Number )
• First Posted: January 30, 2019
• Results First Posted: May 4, 2022
• Last Update Posted: January 13, 2023
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hoffmann-La Roche:

AMD; nAMD; neovascular age-related macular degeneration; choroidal neovascularization secondary to age-related macular degeneration

Additional relevant MeSH terms:

Macular Degeneration; Wet Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Aflibercept; Faricimab; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents