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

Completed · Phase 3

Conditions studied: Branch Retinal Vein Occlusion

In brief

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.

Key facts

Study ID

NCT01521559

Run by

Regeneron Pharmaceuticals

People needed

183

Starts

2012-04-01

Expected to finish

2014-03-01

Last updated by the study team

2014-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — La Jolla, California, United States
• Study site — Mountain View, California, United States
• Study site — Palm Desert, California, United States
• Study site — Sacramento, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Fort Myers, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Stuart, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Winter Haven, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Baltimore (2 Locations), Maryland, United States
• Study site — Hagerstown, Maryland, United States
• Study site — Boston (2 Locations), Massachusetts, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Jackson, Michigan, United States
• Study site — Southfield, Michigan, United States
• Study site — Florissant, Missouri, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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