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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03823300
Registration number
NCT03823300
Ethics application status
Date submitted
29/01/2019
Date registered
30/01/2019
Date last updated
13/01/2023
Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)
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Scientific 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)
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Secondary ID [1]
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2018-004042-42
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Secondary ID [2]
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GR40844
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Wet Macular Degeneration
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Faricimab
Treatment: Drugs - Aflibercept
Treatment: Surgery - Sham Procedure
Experimental: Arm A: Faricimab -
Active Comparator: Arm B: Aflibercept -
Treatment: Drugs: Faricimab
Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
Treatment: Drugs: 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).
Treatment: Surgery: 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.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
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Assessment method [1]
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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.
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Timepoint [1]
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From Baseline through Week 48
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Secondary outcome [1]
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Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
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Assessment method [1]
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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.
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Timepoint [1]
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From Baseline through Week 60
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Secondary outcome [2]
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Change From Baseline in BCVA in the Study Eye Over Time
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Assessment method [2]
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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.
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Timepoint [2]
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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
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Secondary outcome [3]
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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
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, average of Weeks 40, 44, and 48
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Secondary outcome [4]
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Percentage of Participants Gaining =15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, average of Weeks 52, 56, and 60
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Secondary outcome [5]
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Percentage of Participants Gaining =15 Letters From the Baseline BCVA in the Study Eye Over Time
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Assessment method [5]
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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.
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Timepoint [5]
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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
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Secondary outcome [6]
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Percentage of Participants Gaining =10 Letters From the Baseline BCVA in the Study Eye Over Time
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Assessment method [6]
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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.
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Timepoint [6]
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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
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Secondary outcome [7]
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Percentage of Participants Gaining =5 Letters From the Baseline BCVA in the Study Eye Over Time
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Assessment method [7]
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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.
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Timepoint [7]
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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
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Secondary outcome [8]
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Percentage of Participants Gaining =0 Letters From the Baseline BCVA in the Study Eye Over Time
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Assessment method [8]
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0
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.
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Timepoint [8]
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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
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Secondary outcome [9]
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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
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline, average of Weeks 40, 44, and 48
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Secondary outcome [10]
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Percentage of Participants Avoiding a Loss of =15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
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Assessment method [10]
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0
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.
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Timepoint [10]
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Baseline, average of Weeks 52, 56, and 60
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Secondary outcome [11]
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Percentage of Participants Avoiding a Loss of =15 Letters From the Baseline BCVA in the Study Eye Over Time
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Assessment method [11]
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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.
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Timepoint [11]
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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
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Secondary outcome [12]
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Percentage of Participants Avoiding a Loss of =10 Letters From the Baseline BCVA in the Study Eye Over Time
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Assessment method [12]
0
0
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.
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Timepoint [12]
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0
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
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Secondary outcome [13]
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0
Percentage of Participants Avoiding a Loss of =5 Letters From the Baseline BCVA in the Study Eye Over Time
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Assessment method [13]
0
0
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.
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Timepoint [13]
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0
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
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Secondary outcome [14]
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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
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Assessment method [14]
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0
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.
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Timepoint [14]
0
0
Baseline, average of Weeks 40, 44, and 48
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Secondary outcome [15]
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0
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
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Assessment method [15]
0
0
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.
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Timepoint [15]
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0
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
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Secondary outcome [16]
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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
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Assessment method [16]
0
0
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.
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Timepoint [16]
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Baseline, average of Weeks 40, 44, and 48
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Secondary outcome [17]
0
0
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA =69 Letters) in the Study Eye Over Time
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Assessment method [17]
0
0
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.
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Timepoint [17]
0
0
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
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Secondary outcome [18]
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0
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
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Assessment method [18]
0
0
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.
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Timepoint [18]
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0
Baseline, average of Weeks 40, 44, and 48
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Secondary outcome [19]
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0
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA =38 Letters) in the Study Eye Over Time
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Assessment method [19]
0
0
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.
Query!
Timepoint [19]
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0
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
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Secondary outcome [20]
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0
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48
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Assessment method [20]
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0
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.
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Timepoint [20]
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0
Week 48
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Secondary outcome [21]
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0
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60
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Assessment method [21]
0
0
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.
Query!
Timepoint [21]
0
0
Week 60
Query!
Secondary outcome [22]
0
0
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112
Query!
Assessment method [22]
0
0
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.
Query!
Timepoint [22]
0
0
Weeks 108 and 112
Query!
Secondary outcome [23]
0
0
Number of Study Drug Injections Received in the Study Eye Through Week 48
Query!
Assessment method [23]
0
0
Query!
Timepoint [23]
0
0
From Baseline through Week 48
Query!
Secondary outcome [24]
0
0
Number of Study Drug Injections Received in the Study Eye Through Week 60
Query!
Assessment method [24]
0
0
Query!
Timepoint [24]
0
0
From Baseline through Week 60
Query!
Secondary outcome [25]
0
0
Number of Study Drug Injections Received in the Study Eye Through Week 108
Query!
Assessment method [25]
0
0
Query!
Timepoint [25]
0
0
From Baseline through Week 108
Query!
Secondary outcome [26]
0
0
Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48
Query!
Assessment method [26]
0
0
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.
Query!
Timepoint [26]
0
0
From Baseline through Week 48
Query!
Secondary outcome [27]
0
0
Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60
Query!
Assessment method [27]
0
0
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.
Query!
Timepoint [27]
0
0
From Baseline through Week 60
Query!
Secondary outcome [28]
0
0
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Query!
Assessment method [28]
0
0
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.
Query!
Timepoint [28]
0
0
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
Query!
Secondary outcome [29]
0
0
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Query!
Assessment method [29]
0
0
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.
Query!
Timepoint [29]
0
0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
Query!
Secondary outcome [30]
0
0
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Query!
Assessment method [30]
0
0
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.
Query!
Timepoint [30]
0
0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
Query!
Secondary outcome [31]
0
0
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Query!
Assessment method [31]
0
0
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.
Query!
Timepoint [31]
0
0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
Query!
Secondary outcome [32]
0
0
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Query!
Assessment method [32]
0
0
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.
Query!
Timepoint [32]
0
0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
Query!
Secondary outcome [33]
0
0
Percentage of Participants With Absence of Intraretinal Cysts in the Study Eye Over Time
Query!
Assessment method [33]
0
0
Query!
Timepoint [33]
0
0
Up to 112 weeks
Query!
Secondary outcome [34]
0
0
Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48
Query!
Assessment method [34]
0
0
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.
Query!
Timepoint [34]
0
0
Baseline and Week 48
Query!
Secondary outcome [35]
0
0
Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 112
Query!
Assessment method [35]
0
0
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.
Query!
Timepoint [35]
0
0
Baseline and Week 112
Query!
Secondary outcome [36]
0
0
Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 48
Query!
Assessment method [36]
0
0
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.
Query!
Timepoint [36]
0
0
Baseline and Week 48
Query!
Secondary outcome [37]
0
0
Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 112
Query!
Assessment method [37]
0
0
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.
Query!
Timepoint [37]
0
0
Baseline and Week 112
Query!
Secondary outcome [38]
0
0
Percentage of Participants With at Least One Adverse Event
Query!
Assessment method [38]
0
0
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).
Query!
Timepoint [38]
0
0
From first dose of study drug through end of study (up to 112 weeks)
Query!
Secondary outcome [39]
0
0
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Query!
Assessment method [39]
0
0
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).
Query!
Timepoint [39]
0
0
From first dose of study drug through end of study (up to 112 weeks)
Query!
Secondary outcome [40]
0
0
Percentage of Participants With at Least One Non-Ocular Adverse Event
Query!
Assessment method [40]
0
0
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.
Query!
Timepoint [40]
0
0
From first dose of study drug through end of study (up to 112 weeks)
Query!
Secondary outcome [41]
0
0
Plasma Concentration of Faricimab Over Time
Query!
Assessment method [41]
0
0
Faricimab concentration in plasma was determined using a validated immunoassay method.
Query!
Timepoint [41]
0
0
Pre-dose at Baseline, Weeks 4, 16, 20, 48, 76, and 112
Query!
Secondary outcome [42]
0
0
Percentage of Participants Who Tested Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study
Query!
Assessment method [42]
0
0
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.
Query!
Timepoint [42]
0
0
Pre-dose at Baseline, Weeks 4, 20, 48, 76, and 112
Query!
Eligibility
Key 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
Query!
Minimum age
50
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
11/03/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
7/01/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
658
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Query!
Recruitment hospital [1]
0
0
Eyeclinic Albury Wodonga - Albury
Query!
Recruitment hospital [2]
0
0
Marsden Eye Research Centre - Parramatta
Query!
Recruitment hospital [3]
0
0
Strathfield Retina Clinic - Strathfield
Query!
Recruitment hospital [4]
0
0
Sydney Eye Hospital - Sydney
Query!
Recruitment hospital [5]
0
0
Sydney Retina Clinic and Day Surgery - Sydney
Query!
Recruitment hospital [6]
0
0
Sydney West Retina - Westmead
Query!
Recruitment hospital [7]
0
0
Centre For Eye Research Australia - East Melbourne
Query!
Recruitment hospital [8]
0
0
Retina Specialists Victoria - Rowville
Query!
Recruitment hospital [9]
0
0
The Lions Eye Institute - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2640 - Albury
Query!
Recruitment postcode(s) [2]
0
0
2150 - Parramatta
Query!
Recruitment postcode(s) [3]
0
0
2135 - Strathfield
Query!
Recruitment postcode(s) [4]
0
0
2000 - Sydney
Query!
Recruitment postcode(s) [5]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [6]
0
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [7]
0
0
3178 - Rowville
Query!
Recruitment postcode(s) [8]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Hawaii
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Iowa
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maine
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maryland
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Massachusetts
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Minnesota
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New York
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Ohio
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Pennsylvania
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
South Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Tennessee
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Texas
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Utah
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Virginia
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Washington
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
Caba
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
Capital Federal
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
Ciudad Autonoma Buenos Aires
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Mendoza
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
Rosario
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
San Nicolás
Query!
Country [29]
0
0
Austria
Query!
State/province [29]
0
0
Graz
Query!
Country [30]
0
0
Austria
Query!
State/province [30]
0
0
Wien
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
GO
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
SP
Query!
Country [33]
0
0
Bulgaria
Query!
State/province [33]
0
0
Sofia
Query!
Country [34]
0
0
China
Query!
State/province [34]
0
0
Beijing City
Query!
Country [35]
0
0
China
Query!
State/province [35]
0
0
Beijing
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Changchun City
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Chengdu
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Chongqing City
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Chongqing
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Guangzhou City
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Harbin
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Nanjing City
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Shanghai
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Shenyang City
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Tianjin City
Query!
Country [46]
0
0
China
Query!
State/province [46]
0
0
Wenzhou City
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Wuxi
Query!
Country [48]
0
0
Denmark
Query!
State/province [48]
0
0
Glostrup
Query!
Country [49]
0
0
Denmark
Query!
State/province [49]
0
0
Roskilde
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Creteil
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Ecully
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Lyon cedex
Query!
Country [53]
0
0
France
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France
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Szeged
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Lazio
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Izmir
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Funding & Sponsors
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Commercial sector/Industry
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Name
Hoffmann-La Roche
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03823300
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Clinical Trials
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Hoffmann-La Roche
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03823300
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