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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)
Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
Retina Macula Institute
Torrance, California, United States
The Change in Visual Acuity (Number of ETDRS Letters).
The measure the change in ETDRS letters for each treatment group from baseline to 6 months.
Time frame: 6 months
The Change in Central Foveal Thickness (Microns on High Resolution OCT).
The measure the change in central foveal thickness for each treatment group from baseline to 6 months.
Time frame: 6 months
The Change in Macular Leakage on Fluorescein Angiography From Baseline
To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.
Time frame: 6 months
The Change in Mean Macular Sensitivity on Microperimetry From Baseline
To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.
Time frame: 6 months
The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.
To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.
Time frame: 6 months
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