NCT01521559

Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO)

A Double-Masked, Randomized, Active-Controlled Study of the Efficacy, Safety, and Tolerability of Intravitreal Administration of VEGF Trap-Eye (Intravitreal Aflibercept Injection [IAI]) in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, double-masked, randomized, active-controlled, parallel-group, 52-week study to assess the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) compared to laser treatment in patients with macular edema secondary to BRVO.

Conditions

• Branch Retinal Vein Occlusion

Interventions

Type	Name	Description
PROCEDURE	Macular Laser Photocoagulation
DRUG	Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-08-01
• Completion: 2014-03-01
• First posted: 2012-01-30
• Last updated: 2014-11-13
• Results posted: 2014-11-13

Locations

56 sites across 3 countries: United States, Canada, Japan