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

This study is currently recruiting participants.
Verified March 2014 by The Cleveland Clinic
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01613716
First received: June 5, 2012
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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


Estimated Enrollment: 30
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613716

Contacts
Contact: Sunil K Srivastava, MD 216-636-2286 srivass2@ccf.org
Contact: Kimberly M Baynes, COA 216-444-2566 baynesk@ccf.org

Locations
United States, Ohio
Cole Eye Institute, Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Sunil Srivastava, MD    216-636-2286    srivass2@ccf.org   
Contact: Kimberly Baynes    216-444-2566      
Principal Investigator: Sunil K Srivastava, MD         
Sponsors and Collaborators
The Cleveland Clinic
Allergan
Investigators
Principal Investigator: Sunil Srivastava, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01613716     History of Changes
Other Study ID Numbers: 115200
Study First Received: June 5, 2012
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
Diabetes
Macular Edema
Epiretinal Membrane
Vitrectomy

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

ClinicalTrials.gov processed this record on April 16, 2014