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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/NCT04740905
Registration number
NCT04740905
Ethics application status
Date submitted
3/02/2021
Date registered
5/02/2021
Date last updated
18/01/2024
Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion
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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 Macular Edema Secondary to Branch Retinal Vein Occlusion
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Secondary ID [1]
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2020-000440-63
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Secondary ID [2]
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GR41984
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Universal Trial Number (UTN)
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Trial acronym
BALATON
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Macular Edema
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Branch Retinal Vein Occlusion
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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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 Q4W (Part 1), Faricimab PTI (Part 2) - In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
Active Comparator: Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2) - In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
Treatment: Drugs: Faricimab
Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.
Treatment: Drugs: Aflibercept
Aflibercept 2 mg will be administered by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Treatment: Surgery: Sham Procedure
The sham is a procedure that mimics an intravitreal (IVT) 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 treatments 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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Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24
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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 included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors [baseline BCVA (=55 and =54 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
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Timepoint [1]
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From Baseline through Week 24
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Secondary outcome [1]
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Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24
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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 included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors [baseline BCVA (=55 and =54 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
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Timepoint [1]
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Secondary outcome [2]
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Part 1: Percentage of Participants Gaining =15 Letters in BCVA From Baseline in the Study Eye at Week 24
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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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55 and =54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
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Timepoint [2]
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Baseline and Week 24
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Secondary outcome [3]
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Part 1: Percentage of Participants Gaining =15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
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Assessment method [3]
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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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55 and =54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
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Timepoint [3]
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Secondary outcome [4]
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Part 1: Percentage of Participants Gaining =10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
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Assessment method [4]
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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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55 and =54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
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Timepoint [4]
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Secondary outcome [5]
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Part 1: Percentage of Participants Gaining =5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
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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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55 and =54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% 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, and 24
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Secondary outcome [6]
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Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
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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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55 and =54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% 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, and 24
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Secondary outcome [7]
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Part 1: Percentage of Participants Avoiding a Loss of =15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
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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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55 and =54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% 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, and 24
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Secondary outcome [8]
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Part 1: Percentage of Participants Avoiding a Loss of =10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
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Assessment method [8]
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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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55 and =54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% 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, and 24
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Secondary outcome [9]
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Part 1: Percentage of Participants Avoiding a Loss of =5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
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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. 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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55 and =54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
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Timepoint [9]
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Secondary outcome [10]
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Part 1: Percentage of Participants Achieving =84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
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Assessment method [10]
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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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55 and =54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
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Timepoint [10]
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Secondary outcome [11]
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Part 1: Percentage of Participants Achieving =69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
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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 BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55 and =54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% 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, and 24
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Secondary outcome [12]
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Part 1: Percentage of Participants With =38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
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Assessment method [12]
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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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (>38 and =38 letters) and region (U.S. and Canada, Asia, and rest of the world). All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
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Timepoint [12]
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Secondary outcome [13]
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Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24
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Assessment method [13]
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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. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline CST (continuous), and randomization stratification factors [baseline BCVA (=55 and =54 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
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Timepoint [13]
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Secondary outcome [14]
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Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24
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Assessment method [14]
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Absence of diabetic macular edema was defined as achieving a central subfield thickness of <325 microns in the study eye. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55 and =54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
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Timepoint [14]
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Secondary outcome [15]
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Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
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Assessment method [15]
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Intraretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55 and =54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
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Timepoint [15]
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Secondary outcome [16]
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Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
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Assessment method [16]
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Subretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55 and =54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
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Timepoint [16]
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Secondary outcome [17]
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Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
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Assessment method [17]
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Intraretinal fluid and subretinal fluid were measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55 and =54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
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Timepoint [17]
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Secondary outcome [18]
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Part 1: Change From Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24
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Assessment method [18]
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The NEI VFQ-25 captures a patient's perception of vision-related functioning and vision-related quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and 1 item on general health. The composite score ranges from 0 to 100, with higher scores indicating better vision-related functioning. For the ANCOVA analysis, the model uses the non-missing change from baseline in BCVA at Weeks 24 as the response variables adjusted for the treatment group, baseline NEI VFQ-25 Composite Score (continuous), baseline BCVA score (=55 and =54 letters) and region (U.S. and Canada, Asia, and the rest of the world). Observed NEI VFQ-25 assessments were used regardless of the occurrence of intercurrent events. Missing data were not imputed. 95% CI is a rounding of 95.03% CI.
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Timepoint [18]
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Baseline and Week 24
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Secondary outcome [19]
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Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
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Assessment method [19]
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0
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Timepoint [19]
0
0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
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Secondary outcome [20]
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Parts 1 and 2: Percentage of Participants Gaining =15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
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Assessment method [20]
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0
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Timepoint [20]
0
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Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
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Secondary outcome [21]
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Parts 1 and 2: Percentage of Participants Gaining =10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
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Assessment method [21]
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0
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Timepoint [21]
0
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Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
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Secondary outcome [22]
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Parts 1 and 2: Percentage of Participants Gaining =5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
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Assessment method [22]
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0
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Timepoint [22]
0
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Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
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Secondary outcome [23]
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Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
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Assessment method [23]
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0
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Timepoint [23]
0
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Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
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Secondary outcome [24]
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Parts 1 and 2: Percentage of Participants Avoiding a Loss of =15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
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Assessment method [24]
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0
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Timepoint [24]
0
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Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
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Secondary outcome [25]
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0
Parts 1 and 2: Percentage of Participants Avoiding a Loss of =10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
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Assessment method [25]
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0
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Timepoint [25]
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Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
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Secondary outcome [26]
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Parts 1 and 2: Percentage of Participants Avoiding a Loss of =5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
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Assessment method [26]
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0
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Timepoint [26]
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Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
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Secondary outcome [27]
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Parts 1 and 2: Percentage of Participants Achieving =84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
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Assessment method [27]
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Timepoint [27]
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Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
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Secondary outcome [28]
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Parts 1 and 2: Percentage of Participants Achieving =69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
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Assessment method [28]
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0
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Timepoint [28]
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Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
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Secondary outcome [29]
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Parts 1 and 2: Percentage of Participants With =38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
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Assessment method [29]
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Timepoint [29]
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Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
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Secondary outcome [30]
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Parts 1 and 2: Change From Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72
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Assessment method [30]
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0
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Timepoint [30]
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Baseline and Weeks 24, 48, and 72
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Secondary outcome [31]
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Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
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Assessment method [31]
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0
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Timepoint [31]
0
0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Query!
Secondary outcome [32]
0
0
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Query!
Assessment method [32]
0
0
Query!
Timepoint [32]
0
0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Query!
Secondary outcome [33]
0
0
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Query!
Assessment method [33]
0
0
Query!
Timepoint [33]
0
0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Query!
Secondary outcome [34]
0
0
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Query!
Assessment method [34]
0
0
Query!
Timepoint [34]
0
0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Query!
Secondary outcome [35]
0
0
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Query!
Assessment method [35]
0
0
Query!
Timepoint [35]
0
0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Query!
Secondary outcome [36]
0
0
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Query!
Assessment method [36]
0
0
Query!
Timepoint [36]
0
0
Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Query!
Secondary outcome [37]
0
0
Part 2: Percentage of Participants Avoiding a Loss of =15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Query!
Assessment method [37]
0
0
Query!
Timepoint [37]
0
0
Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Query!
Secondary outcome [38]
0
0
Part 2: Percentage of Participants Avoiding a Loss of =10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Query!
Assessment method [38]
0
0
Query!
Timepoint [38]
0
0
Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Query!
Secondary outcome [39]
0
0
Part 2: Percentage of Participants Avoiding a Loss of =5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Query!
Assessment method [39]
0
0
Query!
Timepoint [39]
0
0
Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Query!
Secondary outcome [40]
0
0
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Query!
Assessment method [40]
0
0
Query!
Timepoint [40]
0
0
Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Query!
Secondary outcome [41]
0
0
Part 2: Percentage of Participants on Different Treatment Intervals at Week 68
Query!
Assessment method [41]
0
0
Query!
Timepoint [41]
0
0
Week 68
Query!
Secondary outcome [42]
0
0
Part 2: Number of Study Drug Injections Received in the Study Eye From Week 24 Through Week 72
Query!
Assessment method [42]
0
0
Query!
Timepoint [42]
0
0
From Week 24 to Week 72
Query!
Secondary outcome [43]
0
0
Incidence and Severity of Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale
Query!
Assessment method [43]
0
0
Query!
Timepoint [43]
0
0
From Baseline until end of study (up to 72 weeks)
Query!
Secondary outcome [44]
0
0
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale
Query!
Assessment method [44]
0
0
Query!
Timepoint [44]
0
0
From Baseline until end of study (up to 72 weeks)
Query!
Secondary outcome [45]
0
0
Plasma Concentration of Faricimab Over Time
Query!
Assessment method [45]
0
0
Query!
Timepoint [45]
0
0
Predose at Day 1, Weeks 4, 24, 28, 52, and 72
Query!
Secondary outcome [46]
0
0
Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and During the Study
Query!
Assessment method [46]
0
0
Query!
Timepoint [46]
0
0
Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72
Query!
Eligibility
Key inclusion criteria
- Foveal center-involved macular edema due to branch retinal vein occlusion (BRVO),
diagnosed no longer than 4 months prior to the screening visit
- Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400
approximate Snellen equivalent) on Day 1
- Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition
of good quality retinal images to confirm diagnosis
- For women of childbearing potential: agreement to remain abstinent or use
contraception, and agreement to refrain from donating eggs during the treatment period
and for 3 months after the final dose of study treatment
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Any major illness or major surgical procedure within 1 month before screening
- Uncontrolled blood pressure
- Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to
Day 1
- Pregnant or breastfeeding, or intending to become pregnant during the study
Ocular Exclusion Criteria for Study Eye:
- History of previous episodes of macular edema due to RVO or persistent macular edema
due to RVO diagnosed more than 4 months before screening
- Any current ocular condition which, in the opinion of the investigator, is currently
causing or could be expected to contribute to irreversible vision loss due to a cause
other than macular edema due to RVO in the study eye (e.g., ischemic maculopathy,
Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense
subfoveal hard exudates, or other non-retinal conditions)
- Macular laser (focal/grid) in the study eye at any time prior to Day 1
- Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or
anticipated within 3 months of study start on Day 1
- Any prior or current treatment for macular edema; macular neovascularization,
including diabetic macular edema (DME) and neovascular age-related macular
degeneration (nAMD); and vitreomacular-interface abnormalities, including, but not
restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator,
ocriplasmin, C3F8, air or periocular injection
- Any prior intervention with verteporfin photodynamic therapy, diode laser,
transpupillary thermotherapy, or vitreo-retinal surgery including sheatotomy
- Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex)
and fluocinolone acetonide intravitreal implant (Iluvien)
Ocular Exclusion Criteria for Both Eyes:
- Prior IVT administration of faricimab in either eye
- History of idiopathic or autoimmune-associated uveitis in either eye
- Active periocular, ocular or intraocular inflammation or infection (including
suspected) in either eye on Day 1
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
2/03/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
12/06/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
553
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Query!
Recruitment hospital [1]
0
0
Strathfield Retina Clinic - Strathfield
Query!
Recruitment hospital [2]
0
0
Save Sight Institute - Sydney
Query!
Recruitment hospital [3]
0
0
Sydney Retina Clinic and Day Surgery - Sydney
Query!
Recruitment hospital [4]
0
0
Centre For Eye Research Australia - East Melbourne
Query!
Recruitment hospital [5]
0
0
Retina Specialists Victoria - Rowville
Query!
Recruitment hospital [6]
0
0
The Lions Eye Institute - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2135 - Strathfield
Query!
Recruitment postcode(s) [2]
0
0
2000 - Sydney
Query!
Recruitment postcode(s) [3]
0
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [4]
0
0
3178 - Rowville
Query!
Recruitment postcode(s) [5]
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
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Hawaii
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Minnesota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Missouri
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Nevada
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Jersey
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
South Dakota
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Tennessee
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Texas
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Utah
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
Brazil
Query!
State/province [30]
0
0
RS
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
SC
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
SP
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Beijing
Query!
Country [34]
0
0
China
Query!
State/province [34]
0
0
Changchun
Query!
Country [35]
0
0
China
Query!
State/province [35]
0
0
Chengdu
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Guangzhou City
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Harbin
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Nanjing City
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Shanghai
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Shenyang City
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Tianjin City
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Wenzhou City
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Wuhan
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Zhengzhou
Query!
Country [45]
0
0
Czechia
Query!
State/province [45]
0
0
Ostrava
Query!
Country [46]
0
0
Czechia
Query!
State/province [46]
0
0
Prague
Query!
Country [47]
0
0
Czechia
Query!
State/province [47]
0
0
Sokolov
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Creteil
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Paris
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Freiburg
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Göttingen
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Ludwigshafen
Query!
Country [53]
0
0
Hong Kong
Query!
State/province [53]
0
0
Hong Kong
Query!
Country [54]
0
0
Hong Kong
Query!
State/province [54]
0
0
Mongkok
Query!
Country [55]
0
0
Hungary
Query!
State/province [55]
0
0
Budapest
Query!
Country [56]
0
0
Hungary
Query!
State/province [56]
0
0
Debrecen
Query!
Country [57]
0
0
Hungary
Query!
State/province [57]
0
0
Pécs
Query!
Country [58]
0
0
Hungary
Query!
State/province [58]
0
0
Szeged
Query!
Country [59]
0
0
Israel
Query!
State/province [59]
0
0
Haifa
Query!
Country [60]
0
0
Israel
Query!
State/province [60]
0
0
Jerusalem
Query!
Country [61]
0
0
Israel
Query!
State/province [61]
0
0
Petach Tikva
Query!
Country [62]
0
0
Israel
Query!
State/province [62]
0
0
Rehovot
Query!
Country [63]
0
0
Israel
Query!
State/province [63]
0
0
Tel Aviv
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Lazio
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Lombardia
Query!
Country [66]
0
0
Italy
Query!
State/province [66]
0
0
Toscana
Query!
Country [67]
0
0
Japan
Query!
State/province [67]
0
0
Aichi
Query!
Country [68]
0
0
Japan
Query!
State/province [68]
0
0
Chiba
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Fukuoka
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
Fukushima
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Hokkaido
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Hyogo
Query!
Country [73]
0
0
Japan
Query!
State/province [73]
0
0
Ibaraki
Query!
Country [74]
0
0
Japan
Query!
State/province [74]
0
0
Kyoto
Query!
Country [75]
0
0
Japan
Query!
State/province [75]
0
0
Tokushima
Query!
Country [76]
0
0
Japan
Query!
State/province [76]
0
0
Tokyo
Query!
Country [77]
0
0
Korea, Republic of
Query!
State/province [77]
0
0
Busan
Query!
Country [78]
0
0
Korea, Republic of
Query!
State/province [78]
0
0
Daegu
Query!
Country [79]
0
0
Korea, Republic of
Query!
State/province [79]
0
0
Seongnam-si
Query!
Country [80]
0
0
Korea, Republic of
Query!
State/province [80]
0
0
Seoul
Query!
Country [81]
0
0
Poland
Query!
State/province [81]
0
0
Bydgoszcz
Query!
Country [82]
0
0
Poland
Query!
State/province [82]
0
0
Bytom
Query!
Country [83]
0
0
Poland
Query!
State/province [83]
0
0
Gda?sk
Query!
Country [84]
0
0
Poland
Query!
State/province [84]
0
0
Gliwice
Query!
Country [85]
0
0
Poland
Query!
State/province [85]
0
0
Katowice
Query!
Country [86]
0
0
Poland
Query!
State/province [86]
0
0
Kraków
Query!
Country [87]
0
0
Poland
Query!
State/province [87]
0
0
Piaseczno
Query!
Country [88]
0
0
Poland
Query!
State/province [88]
0
0
Rybnik
Query!
Country [89]
0
0
Poland
Query!
State/province [89]
0
0
Tarnowskie Góry
Query!
Country [90]
0
0
Poland
Query!
State/province [90]
0
0
Warszawa
Query!
Country [91]
0
0
Portugal
Query!
State/province [91]
0
0
Coimbra
Query!
Country [92]
0
0
Portugal
Query!
State/province [92]
0
0
Porto
Query!
Country [93]
0
0
Russian Federation
Query!
State/province [93]
0
0
Baskortostan
Query!
Country [94]
0
0
Russian Federation
Query!
State/province [94]
0
0
Tatarstan
Query!
Country [95]
0
0
Russian Federation
Query!
State/province [95]
0
0
Irkutsk
Query!
Country [96]
0
0
Singapore
Query!
State/province [96]
0
0
Singapore
Query!
Country [97]
0
0
Spain
Query!
State/province [97]
0
0
Navarra
Query!
Country [98]
0
0
Spain
Query!
State/province [98]
0
0
Valencia
Query!
Country [99]
0
0
Spain
Query!
State/province [99]
0
0
Barcelona
Query!
Country [100]
0
0
Spain
Query!
State/province [100]
0
0
Madrid
Query!
Country [101]
0
0
Spain
Query!
State/province [101]
0
0
Valladolid
Query!
Country [102]
0
0
Taiwan
Query!
State/province [102]
0
0
Changhua
Query!
Country [103]
0
0
Taiwan
Query!
State/province [103]
0
0
Taipei
Query!
Country [104]
0
0
Taiwan
Query!
State/province [104]
0
0
Taoyuan
Query!
Country [105]
0
0
Taiwan
Query!
State/province [105]
0
0
Zhongzheng Dist.
Query!
Country [106]
0
0
United Kingdom
Query!
State/province [106]
0
0
Belfast
Query!
Country [107]
0
0
United Kingdom
Query!
State/province [107]
0
0
Bristol
Query!
Country [108]
0
0
United Kingdom
Query!
State/province [108]
0
0
Cardiff
Query!
Country [109]
0
0
United Kingdom
Query!
State/province [109]
0
0
Gloucestershire
Query!
Country [110]
0
0
United Kingdom
Query!
State/province [110]
0
0
Leeds
Query!
Country [111]
0
0
United Kingdom
Query!
State/province [111]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Chugai Pharmaceutical
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled,
parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab
administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a
double-masked period of study without active control to evaluate faricimab administered
according to a personalized treatment interval (PTI) dosing regimen in participants with
macular edema due to branch retinal vein occlusion (BRVO).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04740905
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Public notes
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Contacts
Principal investigator
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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/NCT04740905
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