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

Phase 4

Terminated

• Conditions: Branch Retinal Vein Occlusion; Macular Edema
• Interventions: Device: Sham injection; Drug: Ranibizumab; Procedure: Rescue laser

• Registration Number: NCT01795209
• Lead Sponsor: Seoul National University Bundang Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-19
• Study First Posted: 2013-02-20
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab group	Rescue laser	Patients will receive three monthly injections of 0.5 mg of Lucentis (0.05 ml), followed by retreatment/rescue laser as needed.
Standard of care group	Sham injection	Patients will receive three monthly sham injections, followed by retreatment/rescue laser as needed.
Standard of care group	Rescue laser	Patients will receive three monthly sham injections, followed by retreatment/rescue laser as needed.
Ranibizumab group	Ranibizumab	Patients will receive three monthly injections of 0.5 mg of Lucentis (0.05 ml), followed by retreatment/rescue laser as needed.

Primary Outcome Measures

Name	Time	Method
Time to achieve an improvement of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best-corrected visual acuity	1 year

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline ETDRS letter score over time	6 months and 1 year
Percentage of patients losing < 10 letters in ETDRS letter score from baseline BCVA	6 months and 1 year
Percentage of patients with central foveal thickness (CFT) of < 300 um	6 months and 1 year
Percentage of patients gaining 10 or more letters in ETDRS letter score from baseline BCVA	6 months and 1 year
Percentage of patients gaining < 10 letters in ETDRS letter score from baseline BCVA	6 months and 1 year
Safety outcomes	6 months and 1 year	Frequency, type, and severity of adverse reactions
Proportion of patients with who at least maintain baseline BCVA	6 months and 1 year
Mean change from baseline CFT over time	6 months and 1 year
Mean change from baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) distance activities subscale score	6 months and 1 year
Mean change from baseline in contrast sensitivity	6 months and 1 year
Mean change from baseline in multifocal electroretinogram (mfERG) P1 amplitude	6 months and 1 year
Percentage of patients losing 10 or more letters in ETDRS letter score from baseline BCVA	6 months and 1 year

Trial Locations

Locations (2)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyunggi-do, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of