Multi-Center Uveitis Steriod Treatment (MUST) Trial

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DESCRIPTION (provided by applicant): Uveitis refers to several ocular disorders characterized by intraocular inflammation, and in the aggregate, are major causes of visual loss and blindness in the United States. Because the peak onset of uveitis is in young adulthood, vision loss due to uveitis has a disproportionately greater impact on years of potential vision lost per case than age-related eye diseases. Most of the diseases causing uveitis are chronic and require long-term therapy. Current therapy for patients with severe, vision-threatening uveitis typically involves the use of systemic medications, primarily oral corticosteroids, and supplemented by immunosuppressive drugs in selected situations. The fluocinolone acetonide intraocular implant is a recently developed, surgically implanted reservoir of corticosteroid designed to last three years and to provide long-term control of uveitis. A multicenter, randomized controlled clinical trial, the Multicenter Uveitis Steroid Treatment (MUST) trial, is proposed, which will compare the fluocinolone acetonide implant to "standard therapy" for the treatment of patients with severe, vision-threatening intermediate, posterior, or panuveitis. Patients with active uveitis will be randomized to treatment with either the fluocinolone acetonide implant or "standard therapy" consisting of oral corticosteroids. The design outcome will be visual impairment after two years of treatment; other outcomes include ability to control the uveitis, resolution of macular edema, and ocular and systemic morbidity from both the disease and treatments. Additional benefits include prospective epidemiologic data on the long-term outcomes of uveitis, its complications, treatments, and their complication. This application is for the establishment of a Coordinating Center (CC) for the MUST trial and is submitted in conjunction with applications for the Chairman's Office and the Reading Center. The primary responsibilities of the CC are to: (1) establish and maintain the clinical center research network; (2) provide comprehensive information management systems for MUST including a distributed data system and a study web-site; (3) develop and maintain study documentation, including protocol, handbook, and data collection forms; and (4) assemble, analyze and report data on study performance and trial results.