Ranibizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Fair Vision

• Status: Terminated
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of ranibizumab for the treatment of macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in patients with initial fair visual acuity.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Collaborators: Novartis; Samsung Medical Center
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

1. Foveal center-involving macular edema secondary to BRVO diagnosed within 12 months before study enrollment

2. ETDRS chart BCVA: 63 to 77 letters (20/32 to 20/50 Snellen equivalent)

3. CFT >= 300 um (mean of measurements obtained at screening and Day 0)

4. Signed consent informed

5. male or female, age ≥18 years old

Exclusion Criteria:

1. Prior episode of RVO: Past history of RVO in the study eye diagnosed before 1 year of study enrollment.

2. BCVA improvement >10 letters between screening and Day 0

3. History of other ocular diseases (e.g. diabetic retinopathy, age-related macular degeneration)

4. Laser treatment within 3 months before baseline

5. Intraocular corticosteroid use within 3 months before baseline

6. Anti-vascular endothelial growth factor (VEGF) treatment in the study or fellow eye within 3 months before baseline

7. Intraocular surgery other than cataract surgery, Cataract surgery within 6 months before baseline

8. Stroke or myocardial infarction ≤3 months before baseline

9. Pregnancy or plan to have baby in female