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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema; Epiretinal Membrane
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cole Eye Institute, Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Retinal Thickness	At 3 months, central retinal thickness as measured by optical coherence tomography will be measured	3 months
Visual Acuity	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.	3 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Allergan
• Investigators: Principal Investigator: Sunil Srivastava, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: June 5, 2012
• First Submitted That Met QC Criteria: June 6, 2012
• First Posted (Estimate): June 7, 2012

Study Record Updates

• Last Update Posted (Actual): May 16, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Diabetes; Vitrectomy; Macular Edema; Epiretinal Membrane
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Epiretinal Membrane; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 115200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO