Trial · NCT04740905
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion
NCT04740905, Phase 3, Completed, Hoffmann-La Roche; results first posted 2024-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion. Trials, record NCT04740905. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04740905
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion
- NCT number
- NCT04740905
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 553 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Macular Edema, Branch Retinal Vein Occlusion
- Interventions
- Faricimab, Aflibercept, Sham Procedure
- First posted
- 2021-02-05
- Last updated
- 2024-08-06
- Other registries' IDs
- eudract:2020-000440-63
- Results first posted
- 2024-01-18
Source ClinicalTrials.gov
Registered outcomes48
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24 | From Baseline through Week 24 | 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. |
| Secondary | Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | 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. |
| Secondary | Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Week 24 | Baseline and Week 24 | 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. |
| Secondary | Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | 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. |
| Secondary | Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | 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. |
| Secondary | Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | 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. |
| Secondary | Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | 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. |
| Secondary | 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 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | 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. |
| Secondary | 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 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | 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. |
| Secondary | 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 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | 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. |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 registered outcomesOutcomes48
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24 | From Baseline through Week 24 | Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. | ETDRS Letters | MEAN |
| SECONDARY | Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. | ETDRS Letters | MEAN |
| SECONDARY | Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Week 24 | Baseline and Week 24 | Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | 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 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | 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 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | 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 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 outcomesResults by group1,004
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24 | Arm A: Faricimab Q4W (Part 1) | 16.9 | 95% Confidence Interval 15.7 to 18.1 | ETDRS Letters | |
| Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24 | Arm B: Aflibercept Q4W (Part 1) | 17.5 | 95% Confidence Interval 16.3 to 18.6 | ETDRS Letters | |
| Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24 | Arm A: Faricimab Q4W (Part 1) | Week 4 | 11.5 | 95% Confidence Interval 10.5 to 12.5 | ETDRS Letters |
| Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24 | Arm B: Aflibercept Q4W (Part 1) | Week 4 | 12.4 | 95% Confidence Interval 11.4 to 13.4 | ETDRS Letters |
| Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24 | Arm A: Faricimab Q4W (Part 1) | Week 8 | 13.7 | 95% Confidence Interval 12.6 to 14.7 | ETDRS Letters |
| Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24 | Arm B: Aflibercept Q4W (Part 1) | Week 8 | 15.1 | 95% Confidence Interval 14.1 to 16.2 | ETDRS Letters |
| Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24 | Arm A: Faricimab Q4W (Part 1) | Week 12 | 15.1 | 95% Confidence Interval 14.0 to 16.2 | ETDRS Letters |
| Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24 | Arm B: Aflibercept Q4W (Part 1) | Week 12 | 15.9 | 95% Confidence Interval 14.8 to 17.0 | ETDRS Letters |
| Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24 | Arm A: Faricimab Q4W (Part 1) | Week 16 | 15.5 | 95% Confidence Interval 14.4 to 16.6 | ETDRS Letters |
| Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24 | Arm B: Aflibercept Q4W (Part 1) | Week 16 | 16.5 | 95% Confidence Interval 15.4 to 17.7 | ETDRS Letters |
1 to 10 of 1,004Source ClinicalTrials.gov
See all 1,004 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 (Baseline up to Week 24) | STARTED | Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) | 276 | |
| Part 1 (Baseline up to Week 24) | STARTED | Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2) | 277 | |
| Part 1 (Baseline up to Week 24) | Received at Least One Dose of Study Drug | Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) | 276 | |
| Part 1 (Baseline up to Week 24) | Received at Least One Dose of Study Drug | Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2) | 274 | |
| Part 1 (Baseline up to Week 24) | COMPLETED | Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) | 271 | |
| Part 1 (Baseline up to Week 24) | COMPLETED | Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2) | 274 | |
| Part 1 (Baseline up to Week 24) | NOT COMPLETED | Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) | 5 | |
| Part 1 (Baseline up to Week 24) | NOT COMPLETED | Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2) | 3 | |
| Part 2 (Week 24 to Week 72) | STARTED | Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) | 271 | |
| Part 2 (Week 24 to Week 72) | STARTED | Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2) | 274 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events380
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Arm A: Faricimab Q4W (Part 1) | 10 | 276 | 10 |
| other | COVID-19 | Infections and infestations | Arm B: Aflibercept Q4W (Part 1) | 16 | 274 | 16 |
| other | COVID-19 | Infections and infestations | Arm A: Faricimab Q4W to Faricimab PTI (Part 2) | 32 | 270 | 32 |
| other | COVID-19 | Infections and infestations | Arm B: Aflibercept Q4W to Faricimab PTI (Part 2) | 25 | 267 | 25 |
| other | Hypertension | Vascular disorders | Arm A: Faricimab Q4W (Part 1) | 20 | 276 | 21 |
| other | Hypertension | Vascular disorders | Arm B: Aflibercept Q4W (Part 1) | 7 | 274 | 7 |
| other | Hypertension | Vascular disorders | Arm A: Faricimab Q4W to Faricimab PTI (Part 2) | 14 | 270 | 14 |
| other | Hypertension | Vascular disorders | Arm B: Aflibercept Q4W to Faricimab PTI (Part 2) | 8 | 267 | 8 |
| other | Conjunctival haemorrhage | Eye disorders | Arm A: Faricimab Q4W (Part 1) | 8 | 276 | 9 |
| other | Conjunctival haemorrhage | Eye disorders | Arm B: Aflibercept Q4W (Part 1) | 10 | 274 | 11 |
1 to 10 of 380Source ClinicalTrials.gov
See all 380 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Faricimab Q4W (Part 1) | 1 | 276 |
| Total, all-cause mortality | Arm B: Aflibercept Q4W (Part 1) | 0 | 274 |
| Total, all-cause mortality | Arm A: Faricimab Q4W to Faricimab PTI (Part 2) | 1 | 270 |
| Total, all-cause mortality | Arm B: Aflibercept Q4W to Faricimab PTI (Part 2) | 2 | 267 |
| Total, other adverse events | Arm A: Faricimab Q4W (Part 1) | 62 | 276 |
| Total, other adverse events | Arm B: Aflibercept Q4W (Part 1) | 69 | 274 |
| Total, other adverse events | Arm A: Faricimab Q4W to Faricimab PTI (Part 2) | 92 | 270 |
| Total, other adverse events | Arm B: Aflibercept Q4W to Faricimab PTI (Part 2) | 87 | 267 |
| Total, serious adverse events | Arm A: Faricimab Q4W (Part 1) | 12 | 276 |
| Total, serious adverse events | Arm B: Aflibercept Q4W (Part 1) | 17 | 274 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04740905
GET https://conductscience.org/api/trials/v1/NCT04740905/registered?page=2