Dexamethasone Intravitreal Implant After Vitrectomy For Epiretinal Membrane

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of dexamethasone intravitreal implant (Ozurdex) in combination with pars plana vitrectomy and membrane peeling for idiopathic epiretinal membrane (ERM).

Detailed Description
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Pars plana vitrectomy with membrane peeling has been used for years to successfully to treat ERM (epiretinal membrane). However, despite successful surgery, approximately 10-30% of patients may not experience any improvement in visual acuity (ref. 1-7). Macular causes of unsatisfactory visual outcome following vitrectomy include persistent macular edema and reoccurrence of epiretinal membrane (ref. 1-7). Concomitant administration of intravitreal corticosteroids (triamcinolone acetonide) after pars plana vitrectomy and membrane peeling for epiretinal membrane has been reported to speed up and improve the anatomic and functional outcome (ref 8). Given that intravitreal triamcinolone has been reported to last approximately 113 days ina post-vitrectomy eye (ref. 9); the investigators postulate that a longer-acting corticosteroid such as Ozurdex could not only have the benefits of improved anatomic and functional outcomes, but also a longer sustained effect.

Official Title
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Dexamethasone Intravitreal Implant After Vitrectomy for Idiopathic Epiretinal Membrane

Conditions
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Macular Edema, Epiretinal Membrane

Intervention / Treatment
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* Drug: Dexamethasone Intravitreal Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with idiopathic epiretinal membrane Preoperative visual acuity of snellen equivalent 20/32 or worse Exclusion Criteria: History or presence of any of the following: uveitis macular hole previous vitreoretinal surgery any other retinal pathology that could affect anatomic or functional results Age Related Macular Degeneration Diabetic Retinopathy Diabetic Macular Edema Retinal Vein Occlusion Pre-existing Macular Disease
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 |
| --- | --- |
| Experimental: PPV + MP + DEX<br>Patients will undergo pars plana vitrectomy, membrane peel, and concomitant Ozurdex implant (0.7 mg dose). | Drug: Dexamethasone Intravitreal Implant<br>* Half of the study participants (15 out of 30) will receive one - Dexamethasone Intravitreal Implant 0.7 mg.<br>* Other names: Dexamethasone Intravitreal Implant (Ozurdex);|
| Active Comparator: PPV + MP<br>Patients will undergo pars plana vitrectomy with membrane peel, without Ozurdex implant. | Drug: Dexamethasone Intravitreal Implant<br>* Half of the study participants (15 out of 30) will receive one - Dexamethasone Intravitreal Implant 0.7 mg.<br>* Other names: Dexamethasone Intravitreal Implant (Ozurdex);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in best corrected visual acuity | At all study visits: ETDRS visual acuity will be measured visit excluding post op day 1 (snellen visual acuity will be measured). Intraocular pressure (IOP) will be checked. Spectral Domain Optical Coherence Tomography (OCT). Dilated fundus exam. At Pre Op, Post Op Week 4, 8, 12, 16, 20 and 24 visits: ETDRS visual acuity will be measured. IOP check. Spectral Domain OCT. Fundus photography. Fundus Autofluorescence (AF). Fluorescein Angiography (FA). Dilated Fundus exam. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of persistent macular edema on Central OCT thickness in treatment (PPV + MP + DEX) versus non-treatment (PPV + MP) groups | At all visits: ETDRS visual acuity will be measured except post op day 1 (snellen visual acuity will be measured) Intraocular pressure (IOP) will be checked Spectral Domain Optical Coherence Tomography (OCT) Dilated fundus exam At Pre Op, Post Op Week 4, 8, 12, 16, 20, and 24: ETDRS visual acuity will be measured IOP will be checked Spectral Domain OCT Fundus Photography Fundus Auto Fluorescence (AF) Fluorescein Angiography (FA) Dilated Fundus exam | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epiretinal Membrane, Macular Edema, Dexamethasone Intravitreal Implant (Ozurdex), Pars Plana Vitrectomy