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

Not Applicable

Completed

Brief Summary: 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group 1	Avastin	Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.
Group 1	Ozurdex	Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.
Group 2	Avastin	Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.

Primary Outcome Measures

Name	Time	Method
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 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 Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm	Baseline - Month 6	Total Number of addiitonal Avastin injections during study- From baseline to Month 6

Secondary Outcome Measures

Name	Time	Method
Change in Central Mean Thickness Based on OCT	Baseline to 6 Months	Change in Central Mean Thickness based on OCT from baseline to Month 6t

Locations (2): Retina Vitreous Center
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Toms River, New Jersey, United States
Long Island Vitreoretinal Consultants
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Riverhead, New York, United States