Dexamethasone Intravitreal Implant After Vitrectomy For Epiretinal Membrane

Not Applicable

Terminated

• Conditions: Epiretinal Membrane; Macular Edema
• Interventions: Drug: Dexamethasone Intravitreal Implant

• Registration Number: NCT01410201
• Lead Sponsor: Barnes Retina Institute

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-07-19
• Study Start: 2011-08
• Study First Submitted QC: 2011-08-04
• Study First Posted: 2011-08-05
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Patients with idiopathic epiretinal membrane
• Preoperative visual acuity of snellen equivalent 20/32 or worse

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PPV + MP + DEX	Dexamethasone Intravitreal Implant	Patients will undergo pars plana vitrectomy, membrane peel, and concomitant Ozurdex implant (0.7 mg dose).
PPV + MP	Dexamethasone Intravitreal Implant	Patients will undergo pars plana vitrectomy with membrane peel, without Ozurdex implant.

Primary Outcome Measures

Name	Time	Method
Changes in best corrected visual acuity	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of persistent macular edema on Central OCT thickness in treatment (PPV + MP + DEX) versus non-treatment (PPV + MP) groups	6 months	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

Trial Locations

Locations (3)

The Retina Institute; 🇺🇸 St. Louis, Missouri, United States

St. Lukes Hospital; 🇺🇸 Chesterfield, Missouri, United States

St. Louis Eye Surgery and Laser Center; 🇺🇸 St. Louis, Missouri, United States