Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA… (NCT01521559) | Clinical Trial Compass
CompletedPhase 3
Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO)
United States, Canada, Japan183 participantsStarted 2012-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF