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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Sunil Srivastava, The Cleveland Clinic
ClinicalTrials.gov Identifier:
First received: June 5, 2012
Last updated: March 14, 2016
Last verified: March 2016
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 Intervention Phase
Diabetic Macular Edema
Epiretinal Membrane
Drug: Dexamethasone implant (Ozurdex)
Drug: Ozurdex
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)

Resource links provided by NLM:

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Central Retinal Thickness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    At 3 months, central retinal thickness as measured by optical coherence tomography will be measured

  • Visual Acuity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    ETDRS visual acuity will be measured at 3 months

Enrollment: 30
Study Start Date: July 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ozurdex Drug: Dexamethasone implant (Ozurdex)
Ozurdex .7 mg injected into the treated eye
Drug: Ozurdex

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.

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Sunil Srivastava, PI, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01613716     History of Changes
Other Study ID Numbers: 115200 
Study First Received: June 5, 2012
Last Updated: March 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
Macular Edema
Epiretinal Membrane

Additional relevant MeSH terms:
Epiretinal Membrane
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on May 02, 2016