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Completed

NCT Number: NCT01613716

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

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.

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Key information

Conditions

Diabetic Macular Edema Diabetes Mellitus Endocrine System Diseases Epiretinal Membrane Eye Diseases Glucose Metabolism Disorders Macular Degeneration Macular Edema Metabolic Diseases Nutritional and Metabolic Diseases Retinal Degeneration Retinal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cole Eye Institute, Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ozurdex

Drug

Ozurdex .7 mg injected into the treated eye

Other names: Dexamethasone

Primary outcomes

  1. Central Retinal Thickness

    Time frame: 3 months

    At 3 months, central retinal thickness as measured by optical coherence tomography will be measured

  2. Visual Acuity

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Allergan

Registry information

Acronym: OPERA

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Jun 7, 2012
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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