Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.

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

Intervention / Treatment
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* Drug: dexamethasone intravitreal implant
* Drug: intravitreal bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ozurdex<br>Patients in this group receive Ozurdex at initial visit and at month 4 | Drug: dexamethasone intravitreal implant<br>* Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)<br>* Other names: Ozurdex;|
| Active Comparator: Avastin<br>Patients in this group receive Avastin Q1 month for 5 months. | Drug: intravitreal bevacizumab<br>* Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DME, PDR, Macular Edema, NPDR, Ozurdex, Dexamethasone, Avastin, Bevacizumab