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Clinical Trial Details
Research Study Summary
A clinical trial seeking patients for a research study for the treatment of Diabetic Macular Edema., Non-proliferative Diabetic Retinopathy or Proliferative Diabetic Retinopathy
Research Study Title
Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.
The purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone
implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant
diabetic macular edema.
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Both Male and Female
Both Male and Female ages 18 Years and up
Presence of NPDR or PDR as confirmed by fluorescein angiography
Prior treatment with > = 2 intravitreal anti-VEGF injections but no treatment in last
< 0.1 LogOCT decrease in macular edema on high resolution OCT between initial visit
and following treatment with > = 2 intravitreal anti-VEGF injections
Age 18 years or older
ETDRS Visual acuity between 3 and 78 letters (approximate Snellen equivalent of 20/25
Ability to provide written informed consent
Capable of complying with study protocol.
Intraocular injection of steroid medication within prior 3 months
Evidence of significant geographic atrophy on fluorescein angiography in the opinion
of the treating physician
Concurrent ocular disease (wet AMD, significant ERM, etc) that would limit visual
acuity in the opinion of the treating physician
Prior vitrectomy surgery
Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or
extensive dermal) within 1 month prior to day 1.
Known history of IOP elevation in response to steroid treatment in either eye that
resulted in any of the following: a) = 10 mm Hg increase in IOP in response to
steroid injection, or b) IOP = 25 mm Hg and required 2 or more anti-glaucoma
medications to keep IOP below 21 mm Hg.
Patients who are pregnant.
Unwilling or unable to follow or comply with all study related procedures
Site Locations (1)
||Retina Macula Institute
Gina Kim, B.S
Ron P Gallemore, M.D, Ph.D
Mehran Taban, M.D
Ray Oyakawa, M.D
Behnam Sharareh, B.S
NCT ID: NCT01571232
Date Last Changed: January 13, 2013
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