Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema (NCT01571232) | Clinical Trial Compass
CompletedPhase 2
Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema
United States20 participantsStarted 2012-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Presence of NPDR or PDR as confirmed by fluorescein angiography
* Prior treatment with \>= 2 intravitreal anti-VEGF injections but no treatment in last 4 weeks
* \< 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 to 20/800)
* Ability to provide written informed consent
* Capable of complying with study protocol.
Exclusion Criteria:
* 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
What they're measuring
1
The Change in Visual Acuity (Number of ETDRS Letters).
Timeframe: 6 months
2
The Change in Central Foveal Thickness (Microns on High Resolution OCT).