Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)

Study Overview
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Brief Summary
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The purpose of this study is to compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO)after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).

Official Title
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Comparative Study of Initial Ozurdex (Dexamethasone Implant) Versus Avastin (Bevacizumab) in the Treatment of Macular Edema Following Central Retinal Vein Occlusion (CRVO)

Conditions
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Macular Edema, Central Retinal Vein Occlusion

Intervention / Treatment
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* Drug: Ozurdex
* Drug: Avastin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of central retinal vein occlusion (CRVO) Age 18 years or older ETDRS (Early Treatment Diabetic Retinopathy Study) Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/40 to 20/800 OCT Central foveal thickness >250 microns Negative pregnancy test for women of childbearing potential Ability to provide written informed consent Capable of complying with study protocol Exclusion Criteria: History of glaucoma in the study eye with intraocular pressure >21mmHg on more than one topical medication. Combination drugs are considered more than one medication History of steroid-related glaucoma (steroid response) Previous intraocular injection of steroid medication within 90 days Avastin (bevacizumab) or Lucentis (ranibizumab) within 60 days Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician Previous intraocular surgery (e.g. Cataract Surgery) with in 60 days Concurrent ocular disease that would limit visual acuity in the opinion of the treating physician Dense cataract that precludes clinical examination and retinal imaging of the retina History of allergy to dexamethasone, bevacizumab, betadine Ocular or systemic conditions that may pose a threat to the health of the subject in the opinion of the treating physician Unwilling or unable to follow or comply with all study related procedures Current participation in another clinical medical investigation or trial or has received any investigational drug within 12 weeks prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed. | Drug: Ozurdex<br>* Ozurdex, 0.7mg dexamethasone<br>* Other names: Dexamethasone implant;Drug: Avastin<br>* Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.<br>* Other names: Avastin, bevacizumab;|
| Active Comparator: Group 2<br>Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed. | Drug: Avastin<br>* Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.<br>* Other names: Avastin, bevacizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm | The change in visual acuity (number of ETDRS - Early Treatment Diabetic Retinopathy Study letters), at Month 6 as compared with baseline in each treatment arm | Baseline - Month 6 | 
| The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm | Total Number of addiitonal Avastin injections during study- From baseline to Month 6 | Baseline - Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Central Mean Thickness Based on OCT | Change in Central Mean Thickness based on OCT from baseline to Month 6t | Baseline to 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular Edema, Central Retinal Vein Occlusion