Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections.
Completed · Phase 3
Conditions studied: Retinal Vein Occlusion, Macular Edema
In brief
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 more prior intravitreal anti-VEGF drug injections.
Key facts
- Study ID
- NCT01449682
- Run by
- Retina Macula Institute
- People needed
- 10
- Starts
- 2011-10-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2017-05-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Retina Macula Institute — Torrance, California, United States
Full record on ClinicalTrials.gov
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