Overview

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

Status:
Completed

Trial end date:
2014-03-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Regeneron Pharmaceuticals

Collaborator:

Bayer

Treatments:

Aflibercept

Criteria

Inclusion Criteria:

The following inclusion criteria include, but are not limited to:

1. Adults ≥ 18 years of age with foveal center-involved macular edema (ME) secondary to
BRVO diagnosed within 12 months before the screening visit

2. ETDRS BCVA: letter score of 73 to 24 (20/40 to 20/320) in the study eye at screening
and at day 1

3. Provide signed informed consent

Exclusion Criteria:

The following exclusion criteria include, but are not limited to:

1. Current bilateral manifestation of BRVO

2. Uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous
filtration surgery in either the study eye or the fellow eye

3. Insufficient clearing of macular hemorrhage that would prevent the patient from
receiving laser treatment safely on day 1 (patients that meet this criterion may be
rescreened once the macular hemorrhage resolves)

4. Uncontrolled diabetes mellitus (DM)

5. Previous use of intraocular corticosteroids or anti-angiogenic drugs in the study eye

6. Use of periocular corticosteroids in the study eye within 3 months before day 1

7. Use of intraocular or periocular corticosteroids or anti-angiogenic drugs in the
fellow eye within 3 months before day 1

8. Previous administration of systemic anti-angiogenic medications

9. Panretinal scatter photocoagulation, sector laser photocoagulation, or macular grid
photocoagulation in the study eye