Multi-Center Uveitis Steriod Treatment (MUST) Trial

描述(申请人提供)：葡萄膜炎是指几种以眼内炎症为特征的眼部疾病，总的来说，在美国是导致视力丧失和失明的主要原因。由于葡萄膜炎的发病高峰期是在青壮年，与年龄相关的眼病相比，葡萄膜炎导致的视力丧失对每个病例的潜在视力损失的影响不成比例地更大。大多数引起葡萄膜炎的疾病都是慢性疾病，需要长期治疗。目前对严重威胁视力的葡萄膜炎患者的治疗通常包括使用全身药物，主要是口服皮质类固醇，并在特定情况下辅以免疫抑制药物。氟喹诺酮丙酮眼内植入物是最近开发的一种通过手术植入的皮质类固醇储存库，设计可持续三年，并提供对葡萄膜炎的长期控制。建议进行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，该试验将对严重的、威胁视力的中间葡萄膜炎、后葡萄膜炎或全葡萄膜炎患者的治疗与标准疗法进行比较。活动期葡萄膜炎的患者将被随机分成两组，要么接受氟康奈德植入剂治疗，要么接受由口服皮质类固醇组成的“标准治疗”。设计的结果将是治疗两年后视力受损；其他结果包括控制葡萄膜炎的能力，黄斑水肿的解决，以及疾病和治疗的眼睛和全身发病率。其他好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。本申请是关于建立一个必须审判的协调中心(CC)的申请，与主席办公室和阅读中心的申请一起提交。CC的主要职责是：(1)建立和维护临床中心研究网络；(2)为临床研究中心提供全面的信息管理系统，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、手册和数据收集表格；以及(4)收集、分析和报告研究绩效和试验结果的数据。

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.