Dexamethasone Intravitreal Implant After Vitrectomy For Epiretinal Membrane (OZURDEX2)

Barnes Retina Institute

Status: Terminated

Conditions: Macular Edema; Epiretinal Membrane

Treatments: Drug: Dexamethasone Intravitreal Implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01410201

OZURDEX ERM

Details and patient eligibility

About

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).

Full 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.

Enrollment: 6 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

PPV + MP + DEX

Experimental group

Description:

Patients will undergo pars plana vitrectomy, membrane peel, and concomitant Ozurdex implant (0.7 mg dose).

Treatment:

Drug: Dexamethasone Intravitreal Implant

PPV + MP

Active Comparator group

Description:

Patients will undergo pars plana vitrectomy with membrane peel, without Ozurdex implant.

Treatment:

Drug: Dexamethasone Intravitreal Implant