Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)
This study is currently recruiting participants.
Verified January 2013 by The Cleveland Clinic
Sponsor:
The Cleveland Clinic
Collaborator:
Allergan
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01613716
First received: June 5, 2012
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
This study will examine the use of the dexamethasone implant (Ozurdex) in patients with diabetic 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) |
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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Edema
U.S. FDA Resources
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 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Dexamethasone implant (Ozurdex)
Ozurdex .7 mg injected into the treated eye
The purpose of this study to examine the use of Ozurdex in patients who are undergoing pars plana vitrectomy for macular edema due to diabetic macular edema. 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 diabetic 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:
Patients who are undergoing pars plana vitrectomy for:
- Epiretinal membrane/vitreomacular traction
- 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
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: | January 15, 2013 |
| 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 May 23, 2013