Conditions: Diabetic Macular Edema Non-proliferative Diabetic Retinopathy Proliferative Diabetic Retinopathy
Keywords: Macular Edema DME PDR NPDR Ozurdex Dexamethasone Avastin Bevacizumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: Patients in this group receive Ozurdex at initial visit and at month 4 arm 2: Patients in this group receive Avastin Q1 month for 5 months.

Interventions: intervention 1: dexamethasone intravitreal implant intervention 2: intravitreal bevacizumab
Intervention descriptions: intervention 1: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5) intervention 2: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.

Protocol document: