A Phase 3 interventional study of dexamethasone intravitreal implant (OZURDEX) in Diabetic Macular Edema, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by University Health Network, Toronto · Phase 3, Interventional, and Prevention
The purpose of this study is to assess the efficacy and safety of OZURDEX (dexamethasone intravitreal implant) 0.7 mg administered immediately after phacoemulsification and intraocular lens implantation in type 1 or 2 diabetic patients to prevent the occurrence of post-surgical macular edema (ME).
Treatment group: 24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery Patients will be seen at 1 week pre-operatively (baseline visit), and on the same day post-surgery (visit 1), at 1 week (visit 2), 1 month (visit 3) and 3 months (visit 4).
BCVA, IOP and SD-OCT will be performed at each visit.
University Health Network, Toronto is the lead sponsor of 1,432 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery.
Drug: dexamethasone intravitreal implant (OZURDEX)
intravitreal implant
Also known as: OZURDEX
The primary outcome measure will be the change from baseline for the central retinal thickness (CRT) measured by OCT at 3 months after surgery.
Time frame: 3 months
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone Intravitreal Implant
University Health Network, Toronto →