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G.A. Williams, M.S. Blumenkranz, J.A. Haller, B.D. Kuppermann, Posurdex Study Group; Treatment of Persistent Macular Edema (PME) Associated With Uveitis or Irvine-Gass Syndrome (IGS) With an Intravitreal Bioerodible Sustained Dexmethasone Release Implant; a Prospective Controlled Multi-Center Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2003;44(13):4309.
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Purpose: Clinically significant cystoid macular edema (CME) following cataract extraction, although reduced in incidence since conversion from intra- to extracapular techniques still may occur in up to 19% of patients. Similarly although relatively rare in the general population, CME may be commonly encountered in patients with underlying uveitis. Recent studies have suggested that direct intravitreal injection of steroids may ameliorate macular edema in these inflammation-mediated conditions, although concern exists regarding the lack of a specifically formulated drug suitable for intravitreal injection. The efficacy and potential complications, including infection and elevation of intraocular pressure, associated with this form of therapy are not well defined. The purpose of this study was to prospectively evaluate the safety and efficacy of an intravitreal bioerodible sustained dexamethasone (DEX) release implant (PosurdexTM, Oculex Pharmaceuticals, Sunnyvale, CA) in patients with postoperative and uveitic CME. Methods: 40 patients with persistent CME associated with IGS or uveitis were enrolled. Inclusion criteria included VA of 20/40 or worse, and clinical and angiographic evidence of CME. Exclusion criteria included prior vitrectomy, uncontrolled intraocular pressure or pre-existing ocular disease. Patients also underwent standardized ETDRS VA measurement, fluorescein angiography, and OCT measurement of macular thickness at baseline, and at days 30 and 90 following intravitreal insertion of the steroid implant. Results: 26 patients with IGS were randomly allocated into one of three treatment groups: a 700 mcg DEX implant, a 350 mcg DEX implant, or observation. Patients ranged in age from 45 to 89 years. Median VA was 20/100 with approximately 12% between 20/40 and 20/80. 14 patients with uveitis were randomized into the three treatment groups ranging in age from 15 to 69 years. Median VA was 20/100 at baseline; only 14% of patients had better than 20/100 vision. Results remain masked and will be analyzed after the primary efficacy endpoint late December 2002. Conclusions: Intravitreal sustained steroid therapy was studied in a prospective, randomized, masked, controlled multi-center clinical trial as a potential treatment for persistent CME associated with IGS and uveitis.
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