Purchase this article with an account.
B.D. Kuppermann, M.S. Blumenkranz, J.A. Haller, G.A. Williams, Posurdex Study Group; An Intravitreous Dexamethasone Bioerodible Drug Delivery System for the Treatment of Persistent Diabetic Macular Edema . Invest. Ophthalmol. Vis. Sci. 2003;44(13):4289.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
Purpose: To evaluate the safety and efficacy of a bioerodible polymer implant containing dexamethasone (PosurdexTM, Oculex Pharmaceuticals, Sunnyvale, CA) in patients with persistent clinically significant diabetic macular edema despite prior focal laser therapy. Methods: In this prospective multi-center clinical trial, 171 patients were randomized to treatment with a Posurdex containing either 350 mcg or 700 mcg of dexamethasone, or to observation. Inclusion criteria included visual acuity (VA) of 20/40 to 20/200, and clinical and angiographic evidence of macular edema. Patients were followed for 90 days for efficacy and safety. Study visits were at days 1, 7, 30, 60, and 90. Enrollment was completed in September 2002. Efficacy endpoints included change from baseline in best corrected ETDRS VA and macular edema evaluated by clinical examination, fundus photography, fluorescein angiography, and optical coherence tomography. Safety assessments included intraocular pressure, anterior chamber cell and flare, anterior vitreous cell, cataract development or exacerbation, vitreous haze or retinal obscuration, vitreous or retinal hemorrhage, and retinal detachment or tears. Results: Results remain masked and will be analyzed once the last patient reaches the primary efficacy endpoint in late December 2002. Groups will be identified here as A, B, C. 57 patients were randomized into each group. The baseline characteristics were: Median Age group A 65 years, group B 64, group C 65; Sex group A Male 53%, group B 51%, group C 54%. Patients were primarily Caucasian: group A 72%, group B 75%, group C 72%. Approximately 67% of patients had 20/100 or better vision at baseline in group A, 68% in group B, and 63% in group C. Only 3% of patients had 20/40 vision at baseline in group A, 7% in group B, and 5% in group C. Conclusions: An intravitreous bioerodible dexamethasone drug delivery system for the treatment of diabetic macular edema was evaluated in a prospective, randomized, masked, controlled multi-center clinical trial. Three-month safety and efficacy results are to be presented.
This PDF is available to Subscribers Only