Status:
COMPLETED
Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections.
Lead Sponsor:
Retina Macula Institute
Collaborating Sponsors:
Allergan
Conditions:
Retinal Vein Occlusion
Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular function and recalcitrant macular edema associated with retinal vein occlusion following treatment with 2 or m...
Detailed Description
The efficacy of the DEX implant on macular edema for RVO is well established in multiple clinical trials. However, the duration and frequency of re-treatment have not been extensively explored. In add...
Eligibility Criteria
Inclusion
- Presence of central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO)
- Prior treatment with \>= 2 intravitreal anti-VEGF injections but no treatment in last 45 days.
- Age 18 years or older
- ETDRS Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/25 to 20/800
- Central foveal thickness \>275 microns or presence of cystic edema on OCT studies.
- For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study.
- Ability to provide written informed consent • Capable of complying with study protocol
Exclusion
- History of steroid-related glaucoma (steroid response) requiring more than one topical glaucoma medication.
- Intraocular injection of steroid medication within prior 4 months
- Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician.
- Previous laser photocoagulation within 4 months of study
- Concurrent ocular disease (e.g proliferative diabetic retinopathy, geographic atrophy) that would limit visual acuity in the opinion of the treating physician
- Patients who are pregnant.
- Unwilling or unable to follow or comply with all study related procedures.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01449682
Start Date
October 1 2011
End Date
February 1 2013
Last Update
May 31 2017
Active Locations (1)
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1
Retina Macula Institute
Torrance, California, United States, 90503