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 (VIBRANT)

NCT01521559 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Regeneron Pharmaceuticals
Phase	Phase 3
Status	COMPLETED
Enrolment	183
Start date	2012-04
Completion	2014-03

Conditions

• Branch Retinal Vein Occlusion

Interventions

• Macular Laser Photocoagulation
• Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)

Primary outcomes

• Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF — Baseline to week 24
  Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24. Last observation carried forward (LOCF) method was used to impute missing data.

Countries

United States, Canada, Japan