Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

Completed · Phase 2

Conditions studied: Diabetic Macular Edema, Non-proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy

In brief

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.

Key facts

Study ID

NCT01571232

Run by

Retina Macula Institute

People needed

20

Starts

2012-04-01

Expected to finish

2015-03-01

Last updated by the study team

2021-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Retina Macula Institute — Torrance, California, United States

Full record on ClinicalTrials.gov

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