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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Branch Retinal Vein Occlusion Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ranibizumab group

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

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

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

Rescue laser

Intervention Type PROCEDURE

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

Standard of care group

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

Group Type SHAM_COMPARATOR

Sham injection

Intervention Type DEVICE

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 laser

Intervention Type PROCEDURE

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

Interventions

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Ranibizumab

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

Intervention Type DRUG

Sham injection

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

Intervention Type DEVICE

Rescue laser

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

Intervention Type PROCEDURE

Other Intervention Names

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Lucentis(ranibizumab), 3mg/0.3ml

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No