Multi-Center Uveitis Steriod Treatment (MUST) Trial

多中心葡萄膜炎类固醇治疗 (MUST) 试验

• 批准号: 7434323
• 负责人: Janet T. Holbrook
• 金额: $ 536.95万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-15 至 2012-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7434323
• 关键词: Adrenal Cortex Hormones; Adverse effects; Agreement; Area; Blindness; Chairperson; Chronic; Clinical; Clinical Trials; Collaborations; Communication; Complication; Condition; Data; Data Analyses; Data Collection; Data Reporting; Development; Disease; Documentation; Epidemiology; Eye diseases; Fluocinolone Acetonide; Immunosuppressive Agents; Implant; Inflammation; Inflammatory; Internet; Leadership; Management Information Systems; Monitor; Morbidity - disease rate; Multicenter Studies; National Eye Institute; Optics; Oral; Outcome; Panuveitis; Patient Self-Report; Patients; Performance; Pharmaceutical Preparations; Principal Investigator; Procedures; Progress Reports; Protocols documentation; Publications; Purpose; Quality of life; Randomized; Randomized Controlled Clinical Trials; Rate; Reading; Recruitment Activity; Reporting; Research; Resolution; Safety; Schools; Site; Standards of Weights and Measures; Steroids; System; Systemic Therapy; Therapeutic; Time; Tomogram; United States; United States Food and Drug Administration; Universities; Uveitis; Vision; Vision research; Visual; Visual Acuity; Visual impairment; Wisconsin; Work; age related; base; data management; design; distributed data; handbook; improved; macular edema; prevent; prospective; quality assurance; treatment effect; treatment trial

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.

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，在总体上是视觉丧失和失明的主要原因。由于葡萄膜炎的峰值发作是在年轻的成年期，因此葡萄膜炎引起的视力丧失对与年龄相关的眼部疾病相比，对每病例丧失的潜在视力的影响较大。引起葡萄膜炎的大多数疾病都是慢性的，需要长期治疗。对严重，威胁性葡萄膜炎的患者的目前治疗通常涉及使用全身性药物，主要是口服皮质类固醇，并在某些情况下接受免疫抑制药物补充。眼内植入物是一种最近开发的，外科植入的皮质类固醇的储层，旨在持续三年，并提供对葡萄膜炎的长期控制。提出了一项多中心，随机对照临床试验，多中心葡萄膜炎（必须）试验，该试验将比较荧光素乙烯剂植入物与“标准疗法”，以治疗患有严重，威胁性中等，后，后，后验或副腹炎的患者。活性葡萄膜炎的患者将被随机地用氟乙醇酮植入物或由口服皮质类固醇组成的“标准疗法”。两年后，设计结果将是视觉障碍。其他结果包括能够控制葡萄膜炎，黄斑水肿的分辨率以及疾病和治疗的眼部和全身发病率。其他好处包括有关葡萄膜炎的长期结局，其并发症，治疗及其并发症的前瞻性流行病学数据。该申请是为必须试用的协调中心（CC）建立，并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）为必须提供的全面信息管理系统，包括分布式数据系统和研究网站； （3）制定和维护研究文档，包括协议，手册和数据收集表； （4）组装，分析和报告有关研究绩效和试验结果的数据。