Status:
UNKNOWN
Comparison of Intravitreal Ranibizumab and Macular Laser Photocoagulation for ME Following Branch Retinal Vein Occlusion (BRVO)
Lead Sponsor:
Seoul Retina Investigator Group
Collaborating Sponsors:
Samsung Medical Center
Kyungpook National University Hospital
Conditions:
Branch Retinal Vein Occlusion
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01189526
Start Date
January 1 2009
End Date
August 1 2011
Last Update
August 26 2010
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710