drugset / Trial / 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)

NCT01521559 ↗

Phase 3 Completed 183 enrolled Regeneron Pharmaceuticals Bayer · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2012-04
Primary completion
2013-08
Completion
2014-03

Outcome

Met primary endpoint

registry Macular Laser Photocoagulation Treatment (Control) vs Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321); p = 0.0003; Mean Difference (Net) 26.6 NCT01521559 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Aflibercept Protein / enzyme biologic 2 mg Intravitreal