Overview

This trial is active, not recruiting.

Conditions branch retinal vein occlusion, macular edema
Treatments ranibizumab, sham injection, rescue laser
Phase phase 4
Target VEGF
Sponsor Seoul National University Bundang Hospital
Collaborator Samsung Medical Center
Start date January 2013
End date July 2016
Trial size 19 participants
Trial identifier NCT01795209, B-1207-162-005

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Patients will receive three monthly injections of 0.5 mg of Lucentis (0.05 ml), followed by retreatment/rescue laser as needed.
ranibizumab Lucentis(ranibizumab), 3mg/0.3ml
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
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
(Sham Comparator)
Patients will receive three monthly sham injections, followed by retreatment/rescue laser as needed.
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
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

Primary Outcomes

Measure
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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase 4 Study of Ranibizumab for the Treatment of Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Initial Fair Visual Acuity
Principal investigator Kyu Hyung Park, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Seoul National University Bundang Hospital.