Dexamethasone Intravitreal Implant After Vitrectomy for Idiopathic Epiretinal Membrane
Overview
- Phase
- Not Applicable
- Intervention
- Dexamethasone Intravitreal Implant
- Conditions
- Epiretinal Membrane
- Sponsor
- Barnes Retina Institute
- Enrollment
- 6
- Locations
- 3
- Primary Endpoint
- Changes in best corrected visual acuity
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
Rhonda Weeks
Gaurav K. Shah, MD
Barnes Retina Institute
Eligibility Criteria
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:
- •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
Arms & Interventions
PPV + MP + DEX
Patients will undergo pars plana vitrectomy, membrane peel, and concomitant Ozurdex implant (0.7 mg dose).
Intervention: Dexamethasone Intravitreal Implant
PPV + MP
Patients will undergo pars plana vitrectomy with membrane peel, without Ozurdex implant.
Intervention: Dexamethasone Intravitreal Implant
Outcomes
Primary Outcomes
Changes in best corrected visual acuity
Time Frame: 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 Outcomes
- Incidence of persistent macular edema on Central OCT thickness in treatment (PPV + MP + DEX) versus non-treatment (PPV + MP) groups(6 months)