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

Study Overview
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Brief Summary
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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

Official Title
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A Randomized Trial Comparing Intravitreal Ranibizumab and Macular Laser Photocoagulation for the Treatment of Macular Edema Following Branch Retinal Vein Occlusion

Conditions
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Branch Retinal Vein Occlusion

Intervention / Treatment
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* Drug: Ranibizumab
* Procedure: macular laser photocoagulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVRI<br>IVRI : intravitreal ranibizumab (0.5mg) injection | Drug: Ranibizumab<br>* Ranibizumab 0.5mg Ranibizumab will be administered to patients as multiple intravitreal injections.<br>|
| Active Comparator: Laser<br>Laser : macular laser photocoagulation | Procedure: macular laser photocoagulation<br>* Treatment may include both focal and grid therapy using the laser and contact lens of the investigator's choice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity (ETDRS letters) |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal Thickening | Optical Coherence Tomography measured central retinal thickness | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Branch retinal vein occlusion, macular edema, intravitreal injection, ranibizumab