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J.A. Haller, M.S. Blumenkranz, G.A. Williams, B.D. Kuppermann, Posurdex Study Group; Treatment of Persistent Macular Edema Associated With Central and Branch Retinal Vein Occlusion With Extended Delivery of Intravitreal Dexamethasone . Invest. Ophthalmol. Vis. Sci. 2003;44(13):4311.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: Branch (BRVO) and central retinal vein occlusion (CRVO) are relatively common causes of macular edema with five year incidences of approximately 0.6% and 0.2% respectively. Macular grid photocoagulation has been shown to be effective in reducing vision loss associated with macular edema in BRVO, but not CRVO. The purpose of this study was to evaluate the safety and efficacy of a bioerodible intravitreal implant (PosurdexTM, Oculex Pharmaceuticals, Sunnyvale, CA) providing sustained release of dexamethasone (DEX) for the treatment of persistent macular edema associated with BRVO and CRVO in a prospective, randomized, controlled multi-center clinical trial. Methods: 103 patients with macular edema due to BRVO or CRVO were randomly assigned to one of three treatment modalities: intravitreal insertion of 700 mcg of DEX in a bioerodible polymer matrix, insertion of a similar 350 mcg DEX implant or observation. Patients, surgeons and vision examiners were masked as to which dose of drug was received in the two surgical groups. Eligibility requirements included visual acuity of 20/40 or worse and clinical and angiographic evidence of macular edema refractory to other forms of therapy for a minimum of 90 days. Standardized measurements of visual acuity were made prior to enrollment, and at days 1, 7, 30, 60 and 90. Fluorescein angiography and OCT measurement of macular thickness were performed at baseline and at days 30 and 90, with monitoring for adverse effects at all study visits. Results: The three BRVO treatment groups consisted of 19, 21, and 20 patients respectively, and the CRVO groups of 15, 14, and 14 patients. Patients ranged in age from 43 to 86 years (median 70). Visual acuity at baseline was 20/200 or worse in approximately 45% of patients, and 20/40 to 20/100 in the remainder. Enrollment was completed in September 2002 and 90 day data will be available and unmasked in December 2002. The results including change in visual acuity from baseline, angiographic appearance, and OCT-measured macular thickness for each treatment assignment will be presented. Conclusions: The safety and efficacy of an intravitreal bioerodible sustained steroid release implant for the treatment of persistent macular edema in retinal vein occlusions was studied in a prospective, randomized, masked, controlled multi-center clinical trial.
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