A Randomized Trial Comparing Intravitreal Ranibizumab and Macular Laser Photocoagulation for the Treatment of Macular Edema Following Branch Retinal Vein Occlusion

Seoul Retina Investigator Group1 site in 1 country60 target enrollmentJanuary 2009

ConditionsBranch Retinal Vein Occlusion

InterventionsRanibizumab macular laser photocoagulation

DrugsRanibizumab

Overview

Phase: Phase 3
Intervention: Ranibizumab
Conditions: Branch Retinal Vein Occlusion
Sponsor: Seoul Retina Investigator Group
Enrollment: 60
Locations: 1
Primary Endpoint: Best Corrected Visual Acuity (ETDRS letters)
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to evaluate the efficacy of intravitreal Ranibizumab in comparison with macular laser photocoagulation as treatments for macular edema secondary to branch retinal vein occlusion.

Characteristics of this study is as below

Multicenter, randomized clinical trial. (intravitreal Ranibizumab 0.5mg injection vs. macular laser photocoagulation)
After 48 weeks follow up, functional change(visual acuity)and anatomical change (central retinal thickness) would be evaluated

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

August 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul Retina Investigator Group

Eligibility Criteria

Inclusion Criteria

•Symptom duration \< 6 Months, \> 4 weeks
•Visual acuity - less than 20/40 (73 letters) more than 20/400 (19 letters) in ETDRS chart
•OCT - center involved retinal thickening : \> 250 micrometers
•clear media
•well controlled hypertension (\<140/90mmHg) and diabetes (6.5\<HbA1c\<9.5)
•willing to return for all scheduled visits

Exclusion Criteria

•uveitis,NVG, exudative AMD, diabetic retinopathy, Irvine-Gass syndrome, OIS
•any malignancy
•previous treatment history - laser photocoagulation, intravitreal injection with any drug, vitrectomy
•vitreomacular traction or epiretinal membrane
•intraocular surgery in the study eye within 6 months
•uncontrolled glaucoma ( \> 30mmHg with anti-glaucoma medications)
•optic neuropathy, amblyopia
•A condition that in the opinion of the investigator would preclude a patient's participation in the study