Comparison of Intravitreal Ranibizumab and Macular Laser Photocoagulation for ME Following Branch Retinal Vein Occlusion (BRVO)

Phase 3

• Conditions: Branch Retinal Vein Occlusion
• Interventions: Drug: Ranibizumab; Procedure: macular laser photocoagulation

• Registration Number: NCT01189526
• Lead Sponsor: Seoul Retina Investigator Group

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

1. Multicenter, randomized clinical trial. (intravitreal Ranibizumab 0.5mg injection vs. macular laser photocoagulation)

2. After 48 weeks follow up, functional change(visual acuity)and anatomical change (central retinal thickness) would be evaluated

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Status Verified: 2010-08
• Primary Completion: 2010-08
• Study First Submitted: 2010-08-25
• Study First Submitted QC: 2010-08-25
• Last Update Submitted: 2010-08-25
• Study First Posted: 2010-08-26
• Last Update Posted: 2010-08-26
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVRI	Ranibizumab	IVRI : intravitreal ranibizumab (0.5mg) injection
Laser	macular laser photocoagulation	Laser : macular laser photocoagulation

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity (ETDRS letters)	48 weeks

Secondary Outcome Measures

Name	Time	Method
Retinal Thickening	48 weeks	Optical Coherence Tomography measured central retinal thickness

Trial Locations

Locations (1)

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