Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)

Study Overview
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Brief Summary
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This study will examine the use of the dexamethasone implant (Ozurdex) in patients with macular edema associated with an epiretinal or preretinal membrane requiring surgical intervention. After the surgery is performed (pars plana vitrectomy), an Ozurdex implant will be placed in the eye. Patients will be followed for 1 year.

Detailed Description
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The purpose of this study to examine the use of Ozurdex in patients who are undergoing pars plana vitrectomy for macular edema due to preretinal membranes. Specifically, we will examine its effect on macular edema (measured by OCT), and visual recovery (measured by visual acuity). We will examine its use in patients who underwent pars plana vitrectomy for macular edema with associated taut membrane. This will be a prospective pilot study with patients to receive an Ozurdex implant at the time of vitrectomy.

Official Title
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Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)

Conditions
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Diabetic Macular Edema, Epiretinal Membrane

Intervention / Treatment
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* Drug: Ozurdex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are undergoing pars plana vitrectomy for: Epiretinal membrane/vitreomacular traction or Diabetic macular edema Patients with macular edema as measured by OCT (at least 250 um central subfoveal thickness) Informed consent requirements: All study subjects must agree to participate in the study and provide written informed consent, which will be written in English. Age between 18-85 years old Exclusion Criteria: Age < 18 years or > 85 years History of macular edema due to diseases other than those in the inclusion criteria in the study eye History of active inflammatory eye disease (uveitis) (within 3 months) History of ocular malignancy and/or ocular/orbital irradiation History of recent retinal vein occlusion (within 6 months) History of neovascular age-related macular degeneration or choroidal neovascular membrane [ History of juxtafoveal telangiectasia History of Coat's disease History central serous choroidoretinopathy History of previous infectious retinitis (toxoplasmosis, acute retinal necrosis, tuberculosis, etc) Patients with a history of intraocular infection in the study eye (i.e. viral retinitis, endophthalmitis) Patients who are cognitively impaired or those who are unable to provide informed written consent Patients with a history of glaucoma in the study eye (defined as increased cup to disc ratio with associated nerve damage. Patients with ocular hypertension controlled by topical glaucoma drops (maximum 3) will not be excluded). Patient with recent intravitreal injections of steroids or anti-VEGF medications in the study eye (within past 4 weeks). Patients with recent periocular steroid injection (within past 4 weeks) in the study eye Patients on topical NSAIDS drops (patient will be eligible if they discontinue use of topical NSAIDs at time of study enrollment) in the study eye

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ozurdex<br>Subjects will receive Ozurdex injections and will be monitored for macular edema. | Drug: Ozurdex<br>* Ozurdex .7 mg injected into the treated eye<br>* Other names: Dexamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Retinal Thickness | At 3 months, central retinal thickness as measured by optical coherence tomography will be measured | 3 months | 
| Visual Acuity | ETDRS visual acuity will be measured at 3 months. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Macular Edema, Epiretinal Membrane, Vitrectomy