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NCT04740931 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 729
- Enrollment target
NCT04740931: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT04740931 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 729 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04740931, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 729 participants
- Enrollment target
Study 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 patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).
Primary Outcome
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
Interventions
- PROCEDURE Sham Procedure
- DRUG Faricimab
- DRUG Aflibercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 729 participants |
| Start Date | 2021-03-02 |
| Est. Completion | 2023-07-12 |
| Phase | Phase 3 |
What the finished NCT04740931 record still lists
NCT04740931 is an interventional study that assigns participants to a tested intervention. The registered 729 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Sham Procedure is the first listed.
NCT04740931 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04740931 about?
NCT04740931 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion". 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 stu...
What is the current status of trial NCT04740931?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 729 participants. The study started on 2021-03-02. Estimated completion is 2023-07-12.
What interventions are being tested in trial NCT04740931?
The interventions under investigation include: Sham Procedure (PROCEDURE), Faricimab (DRUG), Aflibercept (DRUG).
Who is sponsoring clinical trial NCT04740931?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04740931's enrollment target sits among peer trials
729 489th of 2000 higher than 1,511 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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