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

Phase 4TerminatedNCT01795209

Seoul National University Bundang Hospital19 enrolled

Overview

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.

Lucentis was approved for ME due to BRVO based on the results from BRAVO study. The inclusion criteria in BRAVO was "best corrected visual acuity (BCVA) 20/40 to 20/320". Therefore, the patients with VA better than 20/40 who are out of inclusion criteria of BRAVO study had no treatment and just wait to reach spontaneous improvement. But, there is unmet needs of these patients and, in actual clinical practice, many retina specialists treat these patients with Ranibizumab. These patients have been experiencing VA improvement after the injection. Based on these clinical backgrounds, the investigator wants to suggest the treatment guidelines in these patients group, which is, early treatment of ranibizumab would be effective and increase patients' QOL. In other words, there are many experiences in these cases among ophthalmologists, but there have been no clinical trials that can endorse the treatments. To confirm the efficacy of ranibizumab in patients with initial fair vision, the investigators started the prospective randomized clinical trial on the efficacy and safety of ranibizumab for the patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Branch Retinal Vein Occlusion Macular Edema

Interventions

RanibizumabDRUG

Loading dose: three monthly intravitreal injections of ranibizumab 0.5 mg Lucentis stop criteria: V/A ≥20/20 and complete disappearance of macular edema Retreatment: visual loss of 5 or more letter compared to previous visit

Sham injectionDEVICE

Three monthly sham injections followed by retreatment (sham injections) as needed Stop criteria: V/A ≥20/20 and complete disappearance of macular edema Retreatment: visual loss of 5 or more letter compared to previous visit

Rescue laserPROCEDURE

In the Lucentis group: performed if BCVA \< 20/40 or CFT ≥ 350um despite of 3 sessions of previous Lucenis injection from Month 6 In the standard of care group: performed if BCVA \< 20/40 or CFT ≥ 350um from Month 3

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Seoul National University Bundang Hospital

Seongnam, Gyunggi-do, South Korea

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Time to achieve an improvement of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best-corrected visual acuity

Time frame: 1 year