Trials / Terminated
TerminatedNCT01410201
Dexamethasone Intravitreal Implant After Vitrectomy For Epiretinal Membrane
Dexamethasone Intravitreal Implant After Vitrectomy for Idiopathic Epiretinal Membrane
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Barnes Retina Institute · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the effect of dexamethasone intravitreal implant (Ozurdex) in combination with pars plana vitrectomy and membrane peeling for idiopathic epiretinal membrane (ERM).
Detailed description
Pars plana vitrectomy with membrane peeling has been used for years to successfully to treat ERM (epiretinal membrane). However, despite successful surgery, approximately 10-30% of patients may not experience any improvement in visual acuity (ref. 1-7). Macular causes of unsatisfactory visual outcome following vitrectomy include persistent macular edema and reoccurrence of epiretinal membrane (ref. 1-7). Concomitant administration of intravitreal corticosteroids (triamcinolone acetonide) after pars plana vitrectomy and membrane peeling for epiretinal membrane has been reported to speed up and improve the anatomic and functional outcome (ref 8). Given that intravitreal triamcinolone has been reported to last approximately 113 days ina post-vitrectomy eye (ref. 9); the investigators postulate that a longer-acting corticosteroid such as Ozurdex could not only have the benefits of improved anatomic and functional outcomes, but also a longer sustained effect.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dexamethasone Intravitreal Implant | Half of the study participants (15 out of 30) will receive one - Dexamethasone Intravitreal Implant 0.7 mg. |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2016-01-01
- Completion
- 2016-01-01
- First posted
- 2011-08-05
- Last updated
- 2016-07-27
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01410201. Inclusion in this directory is not an endorsement.