Status:
COMPLETED
Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO)
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Bayer
Conditions:
Branch Retinal Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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) compare...
Eligibility Criteria
Inclusion
- The following inclusion criteria include, but are not limited to:
- Adults ≥ 18 years of age with foveal center-involved macular edema (ME) secondary to BRVO diagnosed within 12 months before the screening visit
- ETDRS BCVA: letter score of 73 to 24 (20/40 to 20/320) in the study eye at screening and at day 1
- Provide signed informed consent
Exclusion
- The following exclusion criteria include, but are not limited to:
- Current bilateral manifestation of BRVO
- Uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous filtration surgery in either the study eye or the fellow eye
- 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)
- Uncontrolled diabetes mellitus (DM)
- Previous use of intraocular corticosteroids or anti-angiogenic drugs in the study eye
- Use of periocular corticosteroids in the study eye within 3 months before day 1
- Use of intraocular or periocular corticosteroids or anti-angiogenic drugs in the fellow eye within 3 months before day 1
- Previous administration of systemic anti-angiogenic medications
- Panretinal scatter photocoagulation, sector laser photocoagulation, or macular grid photocoagulation in the study eye
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT01521559
Start Date
April 1 2012
End Date
March 1 2014
Last Update
November 13 2014
Active Locations (56)
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1
Phoenix, Arizona, United States
2
Tucson, Arizona, United States
3
Beverly Hills, California, United States
4
La Jolla, California, United States