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

Primary Purpose

Diabetic Macular Edema, Epiretinal Membrane

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ozurdex
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetes, Macular Edema, Epiretinal Membrane, Vitrectomy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cole Eye Institute, Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ozurdex

Arm Description

Subjects will receive Ozurdex injections and will be monitored for macular edema.

Outcomes

Primary Outcome Measures

Central Retinal Thickness
At 3 months, central retinal thickness as measured by optical coherence tomography will be measured
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.

Secondary Outcome Measures

Full Information

First Posted
June 5, 2012
Last Updated
April 17, 2018
Sponsor
The Cleveland Clinic
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01613716
Brief Title
Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)
Acronym
OPERA
Official Title
Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema, Epiretinal Membrane
Keywords
Diabetes, Macular Edema, Epiretinal Membrane, Vitrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ozurdex
Arm Type
Experimental
Arm Description
Subjects will receive Ozurdex injections and will be monitored for macular edema.
Intervention Type
Drug
Intervention Name(s)
Ozurdex
Other Intervention Name(s)
Dexamethasone
Intervention Description
Ozurdex .7 mg injected into the treated eye
Primary Outcome Measure Information:
Title
Central Retinal Thickness
Description
At 3 months, central retinal thickness as measured by optical coherence tomography will be measured
Time Frame
3 months
Title
Visual Acuity
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Srivastava, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cole Eye Institute, Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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