Comparison of Intravitreal Ranibizumab and Macular Laser Photocoagulation for ME Following Branch Retinal Vein Occlusion (BRVO)
NCT ID: NCT01189526
Last Updated: 2010-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2009-01-31
2011-08-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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IVRI
IVRI : intravitreal ranibizumab (0.5mg) injection
Ranibizumab
Ranibizumab 0.5mg Ranibizumab will be administered to patients as multiple intravitreal injections.
Laser
Laser : macular laser photocoagulation
macular laser photocoagulation
Treatment may include both focal and grid therapy using the laser and contact lens of the investigator's choice.
Interventions
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Ranibizumab
Ranibizumab 0.5mg Ranibizumab will be administered to patients as multiple intravitreal injections.
macular laser photocoagulation
Treatment may include both focal and grid therapy using the laser and contact lens of the investigator's choice.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Kyungpook National University Hospital
OTHER
Seoul Retina Investigator Group
NETWORK
Responsible Party
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Samsung Medical Center and Kyungpook National University
Principal Investigators
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Se Woong Kang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Jae Pil Shin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Ophthalmology, Kyungpook National University
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BRVOIVRI
Identifier Type: -
Identifier Source: secondary_id
RVOIVRI
Identifier Type: -
Identifier Source: org_study_id
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