Ozurdex for Macular Edema Post Membrane Peeling

Study Overview
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Brief Summary
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An epiretinal membrane is scar tissue on the retina that can cause blurring and distortion of vision and lead to swelling, or macular edema. Despite surgery to remove the scar tissue(membrane peeling), residual swelling of the retina may continue to interfere with vision. In this study the investigators will inject an implantable steroid device into the back, fluid-filled portion of the eye. Steroids have been found to decrease the swelling in the retina. Ozurdex™ is an implantable steroid. Once implanted, Ozurdex™ is slowly dissolved by the vitreous gel that fills the eye, releasing the steroid. The steroid drug delivery system in this study, known as Ozurdex™ has been FDA-approved by the US Food and Drug Administration (FDA) for decreasing swelling due to another condition in the eye. This study will help to find out whether or not this device Ozurdex™ is also effective for reducing the swelling of the retina in patients who have already had surgery to remove scar tissue on the retina.

Official Title
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Ozurdex in Treatment of Macular Edema Post Membrane Peeling

Conditions
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Macular Edema, Epiretinal Membrane, Cellophane Maculopathy, Retinal Edema

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients with macular edema who have had previous epi-retinal membrane peeling surgery for macular edema associated with epi-retinal membranes. All patients must have clear ocular media/lenses determined visually by the investigator in order to permit good quality stereoscopic fundus photography, fluorescein angiography and ocular coherence tomography. Exclusion Criteria: Best corrected visual acuity 20/50 or better in the study eye Sub-macular hemorrhage in the study eye Sub-retinal fibrosis in the study eye Macular hole in the study eye Active inflammatory disease of the study eye Choroidal neovascularization in the study eye History of other ophthalmic disorders with the exception of cataract or previous cataract extraction in the study eye Active ocular infection in the study eye Previous subfoveal laser treatment in the study eye Previous verteporfin photodynamic therapy in the study eye Any systemic medical condition that would preclude them from undergoing surgery with monitored sedation.

Ages Eligible for Study
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Minimum Age: 21 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Ozurdex<br>Arm 1(control) - Patients who have had epi-retinal membrane peeling and have macular edema at least 3 months (90 days) after surgery. These patients will followed without Ozurdex. The patients will be treated with current standard of care, including topical and intravitreal or subtenon's medication. | |
| Experimental: Ozurdex 3 months after surgery<br>Patients who have had epi-retinal membrane peeling and have residual macular edema 3 months after surgery. These patients will receive an Ozurdex implant | Drug: Dexamethasone<br>* intravitreal implant 0.7 mg 6 month duration<br>* Other names: Ozurdex;|
| Experimental: Ozurdex 6 months or longer after surgery<br>Patients who have had epiretinal membrane peeling and have residual macular edema at least 6 months after surgery | Drug: dexamethasone<br>* intravitreal implant 0.7 mg duration 6 months<br>* Other names: ozurdex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean decrease in area and or volume of central foveal thickness as measured by OCT compared to enrollment |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epiretinal membrane, macular pucker, cellophane maculopathy, macular edema, retinal edema, ozurdex, dexamethasone, intravitreal implant