Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

Phase 2

Completed

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

Interventions: Drug: dexamethasone intravitreal implant
Drug: intravitreal bevacizumab

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Ozurdex	dexamethasone intravitreal implant	Patients in this group receive Ozurdex at initial visit and at month 4
Avastin	intravitreal bevacizumab	Patients in this group receive Avastin Q1 month for 5 months.

Primary Outcome Measures

Name	Time	Method
The Change in Visual Acuity (Number of ETDRS Letters).	6 months	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).	6 months	The measure the change in central foveal thickness for each treatment group from baseline to 6 months.

Secondary Outcome Measures

Name	Time	Method
The Change in Mean Macular Sensitivity on Microperimetry From Baseline	6 months	To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.
The Change in Macular Leakage on Fluorescein Angiography From Baseline	6 months	To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.
The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.	6 months	To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.