Trial | NCT01189526  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    ranibizumab ...

  • Study Participants

    60
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
Study Started
Jan 31
2009
Primary Completion
Aug 31
2010
Study Completion
Aug 31
2011
Anticipated
Last Update
Aug 26
2010
Estimate

Drug Ranibizumab

Ranibizumab 0.5mg Ranibizumab will be administered to patients as multiple intravitreal injections.

Procedure macular laser photocoagulation

Treatment may include both focal and grid therapy using the laser and contact lens of the investigator's choice.

IVRI Experimental

IVRI : intravitreal ranibizumab (0.5mg) injection

Laser Active Comparator

Laser : macular laser photocoagulation

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
No Results Posted