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Nguyen, Quan Dong; Merrill, Pauline T.; Clark, W. Lloyd; Banker, Alay S.; Fardeau, Christine; Franco, Pablo; LeHoang, Phuc; Ohno, Shigeaki; Rathinam, Sivakumar R.; Thurau, Stephan; Abraham, Abu; Wilson, Laura; Yang, Yang; Shams, Naveed (2016): Intravitreal Sirolimus for Noninfectious Uveitis: A Phase III Sirolimus Study Assessing Double-masKed Uveitis TReAtment (SAKURA). In: Ophthalmology, Vol. 123, Nr. 11: S. 2413-2423
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Abstract

Purpose: To evaluate the efficacy and safety of intravitreal sirolimus in the treatment of noninfectious uveitis (NIU) of the posterior segment (i.e., posterior, intermediate, or panuveitis). Design: Phase III, randomized, double-masked, active-controlled, 6-month study with intravitreal sirolimus. Participants: Adults with active NIU of the posterior segment (intermediate, posterior, or panuveitis), defined as a vitreous haze (VH) score >1+. Subjects discontinued NIU medications before baseline, except for systemic corticosteroids, which were allowed only for those already receiving them at baseline and were rapidly tapered after baseline per protocol. Methods: Intravitreal sirolimus assigned 1: 1: 1 at doses of 44 (active control), 440, or 880 mg, administered on Days 1, 60, and 120. Main Outcome Measures: The primary efficacy outcome was the percentage of subjects with VH 0 response at Month 5 (study eye) without use of rescue therapy. Secondary outcomes at Month 5 were VH 0 or 0.5+ response rate, corticosteroid tapering success rate (i.e., tapering to a prednisone-equivalent dosage of <= 5 mg/day), and changes in best-corrected visual acuity (BCVA). Adverse events during the double-masked treatment period are presented. Results: A total of 347 subjects were randomized. Higher proportions of subjects in the intravitreal sirolimus 440 mg (22.8%;P = 0.025) and 880 mg (16.4%;P = 0.182) groups met the primary end point than in the 44 mg group (10.3%). Likewise, higher proportions of subjects in the 440 mg (52.6%;P = 0.008) and 880 mg (43.1%;P = 0.228) groups achieved a VH score of 0 or 0.5+ than in the 44 mg group (35.0%). Mean BCVA was maintained throughout the study in each dose group, and the majority of subjects receiving corticosteroids at baseline successfully tapered off corticosteroids (44 mg [63.6%], 440 mg [76.9%], and 880 mg [66.7%]). Adverse events in the treatment and active control groups were similar in incidence, and all doses were well tolerated. Conclusions: Intravitreal sirolimus 440 mg demonstrated a significant improvement in ocular inflammation with preservation of BCVA in subjects with active NIU of the posterior segment. (C) 2016 by the American Academy of Ophthalmology