Status:
COMPLETED
Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)
Lead Sponsor:
Long Island Vitreoretinal Consultants
Conditions:
Macular Edema
Central Retinal Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01231633
Start Date
September 1 2010
End Date
September 1 2014
Last Update
April 3 2018
Active Locations (4)
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1
Retina Vitreous Center
Toms River, New Jersey, United States, 08755
2
Long Island Vitreoretinal Consultants
Great Neck, New York, United States, 11021
3
Long Island Vitreoretinal Consultants
Hauppauge, New York, United States, 11788
4
Long Island Vitreoretinal Consultants
Riverhead, New York, United States, 11901