At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 30 enrolled
Drug / intervention
Ozurdexdrug
Likely dose
Ozurdex 7 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)
In Brief
A Phase 4 clinical trial evaluating Ozurdex for Diabetic Macular Edema and Epiretinal Membrane. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema, Epiretinal Membrane
CountriesUnited States
CollaboratorsAllergan
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartJul 2012
Primary CompletionDec 2016
Study CompletionFeb 2017
TodayJul 2026
First PostedJun 7, 2012
Enrollment StartJul 1, 2012
Primary CompletionDec 1, 2016
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 14.1 years ago
Interventions
Ozurdexdrug
Ozurdex .7 mg injected into the treated eye