A Pilot Study of the Effectiveness of Intra-operative Ozurdex® in Vitrectomy Surgery for Epiretinal Membranes
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Best corrected visual acuity [ Time Frame: 3 Months ] [ Designated as safety issue: No ]Best corrected visual acuity measured before surgery and 3 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.
- Best corrected visual acuity at 1,4 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Best corrected visual acuity measured at 1,4 and 6 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.
- Retinal thickness and volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]Measure the change in retinal thickness and volume from baseline and at 1, 3, 4, 6 months using optical coherence tomography (OCT).
- Intraocular pressure (IOP) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Change of IOP from baseline will be monitored.
- Cataract progression (if applicable) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]For phakic patients, cataract progression from baseline to the 6 months visit will also be monitored.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Intra-operative Ozurdex (biodegradable 0.7mg dexamethasone implant) post-vitrectomy for epiretinal membrane
biodegradable 0.7mg dexamethasone implant
Other Name: 0.7mg dexamethasone implant
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701518
|Contact: Charlene Mulleremail@example.com|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Charlene Muller 416-480-5091 firstname.lastname@example.org|
|Principal Investigator: Peter J Kertes, MD,CM,FRCSC|
|St. Michael's Hospital||Recruiting|
|Toronto, Ontario, Canada, M5C 2T2|
|Contact: Rajeev Muni, MD, FRCSC (416) 867-7422 email@example.com|
|Principal Investigator: Rajeev Muni, MD,FRCSC|
|Principal Investigator:||Peter J Kertes, MD,CM,FRCSC||Sunnybrook Health Sciences Centre|