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

Sponsor
Seoul Retina Investigator Group
Study ID
NCT01189526
Phase
PHASE3
Status
Unknown

Conditions

  • Branch Retinal Vein Occlusion

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Ranibizumab 0.5mg Ranibizumab will be administered to patients as multiple intravitreal injections.
  • macular laser photocoagulation — PROCEDURE
    Treatment may include both focal and grid therapy using the laser and contact lens of the investigator's choice.

Study Details

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

Key Dates

First listed
Aug 26, 2010
Start date
Jan 31, 2009
Status verified
Aug 2010
Primary completion
Aug 31, 2010
Completion
Aug 31, 2011

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IVRI
    IVRI : intravitreal ranibizumab (0.5mg) injection
  • Active Comparator: Laser
    Laser : macular laser photocoagulation

Primary Outcome Measure

Best Corrected Visual Acuity (ETDRS letters) [ Time Frame: 48 weeks ]

Central Contacts