Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)
Status: | Completed |
---|---|
Conditions: | Cardiology, Ocular |
Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | September 2010 |
End Date: | September 2014 |
Comparative Study of Initial Ozurdex (Dexamethasone Implant) Versus Avastin (Bevacizumab) in the Treatment of Macular Edema Following Central Retinal Vein Occlusion (CRVO)
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).
injections in eyes with macular edema following central retinal vein occlusion (CRVO)after
initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).
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
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