Reading Center: Multicenter Uveitis Steroid Trial

阅读中心：多中心葡萄膜炎类固醇试验

• 批准号: 7100212
• 负责人: MICHAEL M ALTAWEEL
• 金额: $ 19.1万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 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 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7100212
• 关键词: bioimaging /biomedical imaging; clinical research; clinical trials; cooperative study; corticosteroids; eye fundus photography; fluorescein angiography; hormone therapy; human subject; human therapy evaluation; image processing; implant; longitudinal human study; medical complication; medical implant science; optical tomography; outcomes research; patient oriented research; retinography; steroid hormone; uveitis

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.

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（必须）试验将是一项多中心，随机对照临床试验，将氟固醇乙烯剂植入物与“标准疗法”进行比较，以治疗严重，视力威胁性中间，后验或panuveisis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”。补充免疫抑制药物将根据标准化指南使用。设计结果将是视力的丧失；其他结果包括控制葡萄膜炎的能力，黄斑水肿（这些患者视觉丧失的主要原因）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。我们建议在威斯康星大学 - 麦迪逊分校（UW RC）建立必要试验的阅读中心。立体颜色的眼底照片和荧光素血管造影和眼相干性断层图（OCT扫描）将进行评估，以了解黄斑水肿的存在和严重程度（视网膜增厚黄斑中心的程度，以及增厚，囊状变化和荧光素泄漏的区域）。还将评估照片和血管造影，以评估血管非灌注，出血，视网膜脱落，前膜，青光眼椎间盘的变化以及核和后囊下白内障。 UW RC将负责提出和实施成像和分级协议，监视和控制成像和分级的质量，维护适当的组织和程序以处理研究图像和分级数据，并将分级数据汇总到分析变量中。与研究主席办公室，协调中心和其他调查人员合作，UW RC将参与必须试用的设计，进行，分析和报告。