Macular Edema Clinical Trial
Official title:
A Prospective Multicentre Pilot Study of the Effectiveness of an Intra-operative Intravitreal Sustained Release Dexamethasone Implant (Ozurdex®) in Vitrectomy Surgery for Epiretinal Membranes
To determine if an intravitreal sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes is safe and effective to decrease the macular edema, as demonstrated by a gain in vision and decreased in retinal thickness and volume.
We believe that the use of intravitreal corticosteroids post-operatively has the capacity to
mitigate much of the residual swelling and retinal thickening that is seen after vitrectomy
for epiretinal membranes. The unique pharmacokinetics of the sustained released
dexamethasone implant (Ozurdex®) makes it an ideal delivery system to use post-vitrectomy
for epiretinal membrane surgery. Its duration of action and its drug delivery
characteristics over 6 months approximately match the post-operative time course of healing
and remodeling in an edematous retina.
This is a prospective, multicentre, pilot study evaluating the efficacy of an intravitreal
sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in
15 patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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