NCT04740905

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 553 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Macular Edema
• Branch Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	Faricimab	Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.
DRUG	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).
PROCEDURE	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.

Timeline

• Start date: 2021-03-02
• Primary completion: 2022-07-06
• Completion: 2023-06-12
• First posted: 2021-02-05
• Last updated: 2024-08-06
• Results posted: 2024-01-18

Locations

150 sites across 22 countries: United States, Argentina, Australia, Austria, Brazil, China, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Poland, Portugal, Russia, Singapore, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study