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NCT01613716 · ClinicalTrials.gov registry record · Phase 4
Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)
A Phase 4 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT01613716: Completed Phase 4 study, sponsored by The Cleveland Clinic.
NCT01613716 is a Phase 4 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01613716, a Phase 4 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
At 3 months, central retinal thickness as measured by optical coherence tomography will be measured
Interventions
- DRUG Ozurdex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-07 |
| Est. Completion | 2017-02 |
| Phase | Phase 4 |
What the finished NCT01613716 record still lists
NCT01613716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Ozurdex is the first listed.
NCT01613716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01613716 about?
NCT01613716 is a clinical study titled "Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)". 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 w...
What is the current status of trial NCT01613716?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2012-07. Estimated completion is 2017-02.
What interventions are being tested in trial NCT01613716?
The interventions under investigation include: Ozurdex (DRUG).
Who is sponsoring clinical trial NCT01613716?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01613716's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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