Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

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.

This is an open-label, Phase II comparative study of an intravitreal dexamethasone implant versus intravitreal bevacizumab (Avastin) in 20 patients with recalcitrant diabetic macular edema and prior treatment with ≥ 2 intravitreal anti-VEGF injections.

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