Study to Assess the Clinical Efficacy and Safety of VEGF Trap-Eye (Intravitreal Aflibercept Injection [IAI]), Also Commercially Known as EYLEA™ in Patients With Branch Retinal Vein Occlusion (BRVO)



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:April 2012
End Date:April 2014
Contact:Clinical Trials Administrator
Email:clinicaltrials@regeneron.com

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This is a phase 3, double-masked, randomized, active-controlled, parallel-group, 52-week
study to assess the efficacy and safety of VEGF Trap-Eye compared to laser treatment in
patients with macular edema secondary to BRVO.


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
We found this trial at
19
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Charleston, South Carolina 29412
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