Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

• The change in visual acuity (number of ETDRS letters). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  The measure the change in ETDRS letters for each treatment group from baseline to 6 months.
• The change in central foveal thickness (microns on high resolution OCT). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  The measure the change in central foveal thickness for each treatment group from baseline to 6 months.

• The change in macular leakage on fluorescein angiography from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.
• The change in mean macular sensitivity on microperimetry from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.
• The change in mean central amplitude on multi-focal ERG from baseline. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.

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.

• Diabetic Macular Edema.
• Non-proliferative Diabetic Retinopathy
• Proliferative Diabetic Retinopathy

• Drug: dexamethasone intravitreal implant
  Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)
  Other Name: Ozurdex
• Drug: intravitreal bevacizumab
  Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
  Other Name: Avastin

• Active Comparator: Ozurdex
  Patients in this group receive Ozurdex at initial visit and at month 4
  Intervention: Drug: dexamethasone intravitreal implant
• Active Comparator: Avastin
  Patients in this group receive Avastin Q1 month for 5 months.
  Intervention: Drug: intravitreal bevacizumab

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