Multi-Center Uveitis Steriod Treatment (MUST) Trial

描述（由申请人提供）：葡萄膜炎是指以眼内炎症为特征的几种眼部疾病，总体上是美国视力丧失和失明的主要原因。由于葡萄膜炎的发病高峰是在青年期，因此葡萄膜炎引起的视力丧失对每例潜在视力丧失年数的影响比年龄相关性眼病大得多。大多数引起葡萄膜炎的疾病是慢性的，需要长期治疗。目前对严重的、威胁视力的葡萄膜炎患者的治疗通常涉及使用全身性药物，主要是口服皮质类固醇，并在选定的情况下辅以免疫抑制药物。醋酸氟轻松眼内植入物是最近开发的，手术植入的皮质类固醇储库，设计持续三年，并提供长期控制葡萄膜炎。一项多中心、随机对照临床试验，即多中心葡萄膜炎类固醇治疗（MUST）试验，拟将氟轻松植入剂与“标准治疗”进行比较，用于治疗严重的、威胁视力的中间葡萄膜炎、后葡萄膜炎或全葡萄膜炎。患有活动性葡萄膜炎的患者将随机接受氟轻松植入治疗或由口服皮质类固醇组成的“标准治疗”。设计结果将是治疗两年后的视力损害;其他结果包括控制葡萄膜炎的能力、黄斑水肿的消退以及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的长期结果、其并发症、治疗及其并发症的前瞻性流行病学数据。本申请为建立MUST试验协调中心（CC），与主席办公室和阅读中心的申请一并提交。CC的主要职责是：（1）建立和维护临床中心研究网络;（2）为MUST提供综合信息管理系统，包括分布式数据系统和研究网站;（3）开发和维护研究文件，包括方案、手册和数据收集表;以及（4）收集、分析和报告研究性能和试验结果数据。

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.