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

Seoul National University

Status and phase: Terminated; Phase 4

Conditions: Macular Edema; Branch Retinal Vein Occlusion

Treatments: Drug: Ranibizumab; Device: Sham injection; Procedure: Rescue laser

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01795209

B-1207-162-005 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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19 participants in 2 patient groups

Ranibizumab group

Experimental group

Description:

Patients will receive three monthly injections of 0.5 mg of Lucentis (0.05 ml), followed by retreatment/rescue laser as needed.

Treatment:

Procedure: Rescue laser

Drug: Ranibizumab

Standard of care group

Sham Comparator group

Description:

Patients will receive three monthly sham injections, followed by retreatment/rescue laser as needed.

Treatment:

Procedure: Rescue laser

Device: Sham injection