Reading Center: Multicenter Uveitis Steroid Trial

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DESCRIPTION (provided by applicant): Uveitis is a major cause of visual loss and blindness in the United States. The Multicenter Uveitis Steroid Treatment (MUST) Trial will be a multicenter, randomized controlled clinical trial to 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. Supplementary immunosuppressive drugs will be used according to standardized guidelines. The design outcome will be loss of visual acuity; other outcomes include ability to control the uveitis, resolution of macular edema (a major cause of visual loss in these patients), and ocular and systemic morbidity from both the disease and the treatments. Additional benefits include prospective epidemiologic data on the long-term outcomes of uveitis, its complications, treatments and their complications. We propose to establish a Reading Center for the MUST Trial at the University of Wisconsin - Madison (UW RC). Stereoscopic color fundus photographs and fluorescein angiograms and ocular coherence tomograms (OCT scans), will be evaluated for presence and severity of macular edema (degree of retinal thickening macular center, and areas of thickening, cystoid change, and fluorescein leakage). Photographs and angiograms will also be assessed for vascular nonperfusion, hemorrhage, retinal detachment, epiretinal membrane, glaucomatous disc changes, and nuclear and posterior subcapsular cataract. The UW RC will be responsible for proposing and implementing imaging and grading protocols, monitoring and controlling the quality of imaging and grading, maintaining appropriate organization and procedures to handle study images and grading data, and summarizing grading data into analysis variables. In collaboration with the Study Chairman's Office, the Coordinating Center, and other investigators, the UW RC will participate in the design, conduct, analysis and reporting of the MUST Trial.