Comparison of Intravitreal Ranibizumab and Macular Laser Photocoagulation for ME Following Branch Retinal Vein Occlusion (BRVO)
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|ClinicalTrials.gov Identifier: NCT01189526|
Recruitment Status : Unknown
Verified August 2010 by Seoul Retina Investigator Group.
Recruitment status was: Recruiting
First Posted : August 26, 2010
Last Update Posted : August 26, 2010
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
|Condition or disease||Intervention/treatment||Phase|
|Branch Retinal Vein Occlusion||Drug: Ranibizumab Procedure: macular laser photocoagulation||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized Trial Comparing Intravitreal Ranibizumab and Macular Laser Photocoagulation for the Treatment of Macular Edema Following Branch Retinal Vein Occlusion|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||August 2010|
|Estimated Study Completion Date :||August 2011|
IVRI : intravitreal ranibizumab (0.5mg) injection
Ranibizumab 0.5mg Ranibizumab will be administered to patients as multiple intravitreal injections.
Active Comparator: Laser
Laser : macular laser photocoagulation
Procedure: macular laser photocoagulation
Treatment may include both focal and grid therapy using the laser and contact lens of the investigator's choice.
- Best Corrected Visual Acuity (ETDRS letters) [ Time Frame: 48 weeks ]
- Retinal Thickening [ Time Frame: 48 weeks ]Optical Coherence Tomography measured central retinal thickness
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189526
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: Song Ee Chung, M.D. firstname.lastname@example.org|
|Sub-Investigator: Song Ee Chung, M.D.|
|Sub-Investigator: Yun Taek Kim, M.D.|
|Principal Investigator:||Se Woong Kang, M.D.||Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine|
|Principal Investigator:||Jae Pil Shin, M.D.||Department of Ophthalmology, Kyungpook National University|