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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01613716
Recruitment Status : Completed
First Posted : June 7, 2012
Results First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Information provided by (Responsible Party):
Sunil Srivastava, The Cleveland Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Epiretinal Membrane Drug: Ozurdex Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)
Actual Study Start Date : July 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Ozurdex
Subjects will receive Ozurdex injections and will be monitored for macular edema.
Drug: Ozurdex
Ozurdex .7 mg injected into the treated eye
Other Name: Dexamethasone

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients who are undergoing pars plana vitrectomy for:

    • Epiretinal membrane/vitreomacular traction or
    • Diabetic macular edema
  2. Patients with macular edema as measured by OCT (at least 250 um central subfoveal thickness)
  3. Informed consent requirements: All study subjects must agree to participate in the study and provide written informed consent, which will be written in English.
  4. Age between 18-85 years old

Exclusion Criteria:

  1. Age < 18 years or > 85 years
  2. 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)
  3. Patients with a history of intraocular infection in the study eye (i.e. viral retinitis, endophthalmitis)
  4. Patients who are cognitively impaired or those who are unable to provide informed written consent
  5. 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).
  6. Patient with recent intravitreal injections of steroids or anti-VEGF medications in the study eye (within past 4 weeks).
  7. Patients with recent periocular steroid injection (within past 4 weeks) in the study eye
  8. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01613716

United States, Ohio
Cole Eye Institute, Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Sunil Srivastava, MD The Cleveland Clinic

Responsible Party: Sunil Srivastava, PI, The Cleveland Clinic Identifier: NCT01613716     History of Changes
Other Study ID Numbers: 115200
First Posted: June 7, 2012    Key Record Dates
Results First Posted: May 16, 2018
Last Update Posted: May 16, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sunil Srivastava, The Cleveland Clinic:
Macular Edema
Epiretinal Membrane

Additional relevant MeSH terms:
Macular Edema
Epiretinal Membrane
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action