Reading Center: Multicenter Uveitis Steroid Trial

描述（由申请人提供）：葡萄膜炎是美国视力丧失和失明的主要原因。多中心葡萄膜炎类固醇治疗（MUST）试验将是一项多中心、随机对照临床试验，比较氟西诺酮植入物与“标准疗法”治疗严重、威胁视力的中度、后侧或全葡萄膜炎患者。活动性葡萄膜炎患者将随机接受氟西诺酮植入治疗或口服皮质类固醇的“标准治疗”。补充免疫抑制药物将根据标准化指南使用。设计的结果将是视力丧失；其他结果包括控制葡萄膜炎的能力，黄斑水肿（这些患者视力丧失的主要原因）的消退，疾病和治疗引起的眼部和全身发病率。其他益处包括关于葡萄膜炎、其并发症、治疗及其并发症的长期结局的前瞻性流行病学数据。我们建议在威斯康辛大学麦迪逊分校（uwrc）为MUST试验建立一个阅读中心。立体彩色眼底照片、荧光素血管造影和眼相干断层扫描（OCT扫描）将评估黄斑水肿的存在和严重程度（黄斑中心视网膜增厚程度、增厚区域、囊样改变和荧光素渗漏）。照片和血管造影也将评估血管不灌注，出血，视网膜脱离，视网膜前膜，青光眼椎间盘改变，核和后囊下白内障。UW研究中心将负责提出和实施成像和分级方案，监测和控制成像和分级的质量，维护适当的组织和程序来处理研究图像和分级数据，并将分级数据汇总为分析变量。西澳大学研究中心将与研究主席办公室、协调中心和其他研究人员合作，参与MUST试验的设计、实施、分析和报告。

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.