Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for ME Secondary to BRVO

Study Overview
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Brief Summary
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To investigate the efficacy of laser photocoagulation combined with ranibizumab intravitreal injection in macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in long term.

Detailed Description
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To investigate the efficacy of ranibizumab intravitreal injections-driven by achieving vision acuity stabilization compared to combination with laser photocoagulation in Chinese patients with visual impairment in ME due to BRVO. The result of the trial will be used to support new therapy in the BRVO in China.

Official Title
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The Randomized Double-blind Controlled Clinical Trial of Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for Macular Edema Secondary to Branch Retinal Vein Occlusion

Conditions
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Branch Retinal Vein Occlusion, Ranibizumab, Laser Photocoagulation

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Male or female Chinese patients ≥ 18 years of age with BRVO Visual impairment due to ME secondary to BRVO in at least one eye with BCVA score between 73 and 24 and at least 24 letters in the other eye Exclusion Criteria: Pregnant or nursing (lactating) women or women of child-bearing potential without using effective contraception Stroke or myocardial infarction less than 3 months prior to screening visit Renal failure or creatinine levels > 2.0 mg/dl Uncontrolled hypertension Active ocular infection or intraocular inflammation in any eye Neovascularization of the iris or neovascular glaucoma in any eye History of uveitis or vitreomacular traction in any eye Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye Glaucoma or intraocular pressure (IOP) ≥ 24 mmHg in study eye Active proliferative diabetic retinopathy in study eye Use of other investigational drugs within 30 days and systemic vascular endothecial growth factor (VEGF) antagonism drugs within 6 months prior to baseline visit Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening History of vitrectomy in study eye Other protocol defined inclusion /exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranibizumab only<br>Sham macular laser photocoagulation treatment after third ranibizumab injection with PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization Interventions :Ranibizumab injection Interventions :Sham macular laser | Drug: Ranibizumab<br>* all subjections received 3+PRN ranibizumab injections by BCVA stabilization<br>* Other names: Lucentis;|
| Experimental: Ranibizumab combined macular laser<br>Macular laser photocoagulation treatment after third ranibizumab injection with PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization Interventions :Ranibizumab injection Interventions :Macular laser photocoagulation | Procedure: Ranibizumab combined macular laser<br>* subjects in one group receive both macular laser photocoagulation and ranibizumab injections but ones in the other group just received ranibizumab injection.<br>Drug: Ranibizumab<br>* all subjections received 3+PRN ranibizumab injections by BCVA stabilization<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity changes | comparing the changes of visual acuity between the two groups | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser Photocoagulation, Ranibizumab, Branch Retinal Vein Occlusion, Vascular Endothecial Growth Factor