Clinical Trials Directory

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

TypeNameDescription
DRUGDexamethasone Intravitreal ImplantHalf 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.