Subconjunctival Sirolimus for Treatment of Autoimmune Active Anterior Uveitis

西罗莫司结膜下注射治疗自身免疫性前葡萄膜炎 临床方案支持合同，旨在获得开发、设计、解释和评估临床试验、流行病学和自然病史研究的外部支持。此外，它还将提供涉及眼部疾病和视力障碍的结果研究以及一些临床前研究。重点应放在研究的设计和这些研究产生的数据的收集、分析和解释上，以及支持和监测患者的安全性和随访。承包商还应按照工作说明书中的说明，为特定的临床研究数据库、成本效益和经济分析、生活质量评估和结果研究提供分析和数据管理支持。这将包括但不限于以下领域：医疗保险和其他医疗保健数据库的分析；对现有NEI数据库的评估，如集中的NEI内部研究数据库、眼病病例对照研究、早期治疗糖尿病视网膜病变研究、Framingham Eye研究以及内部艾滋病和葡萄膜炎数据库。 《临床方案》的目标： 葡萄膜炎是一种炎症状态，患者自身的免疫系统攻击眼睛，导致眼睛发炎和视力丧失。葡萄膜炎患者可以用免疫抑制药物治疗，以减少炎症和防止视力丧失。 -西罗莫司是美国食品和药物管理局(FDA)批准的一种免疫抑制药物，用于预防肾移植后的器官排斥反应。研究人员认为，西罗莫司可能会影响免疫系统中可能是葡萄膜炎重要原因的部分，并可能减少导致葡萄膜炎的炎症。 -在这项研究中，西罗莫司将作为注射在您的眼睛外层下。FDA已经允许西罗莫司在这项研究中进行研究使用。 目标： -确定结膜下注射西罗莫司治疗葡萄膜炎是否安全。 -看看西罗莫司是否是治疗葡萄膜炎的有效方法。

Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveitis Clinical Protocol support contract designed to attain extramural support for developing, designing, interpreting, and evaluating clinical trials, epidemiologic and natural history studies. In addition, it will provide for outcomes research involving eye diseases and visual disorders and some preclinical studies. The focus shall be on the design of studies and the collection, analysis, and interpretation of data emanating from these studies, as well as support, and monitoring patient safety and follow-up. Contractor shall also provide analytical and data management support, as described in the work statement, for specified clinical research data bases, cost-effectiveness and economic analyses, quality of life assessment and outcomes research. This will include, but not be limited to, the following areas: analysis of Medicare and other health care databases; evaluation of existing NEI databases such as, centralized NEI Intramural Research database, the Eye Disease Case Control Study, Early Treatment Diabetic Retinopathy Study, Framingham Eye Study, and intramural AIDS and uveitis databases. Objective of Clinical Protocol: Uveitis is an inflammatory condition in which the patient's own immune system attacks the eye, causing eye inflammation and vision loss. Patients with uveitis may be treated with immunosuppressive medications to reduce the inflammation and prevent vision loss. - Sirolimus is an immunosuppressive medication that is approved by the U.S. Food and Drug Administration (FDA) to prevent organ rejection following a kidney transplant. Researchers think that sirolimus may affect the part of the immune system that may be an important cause of uveitis, and may decrease the inflammation that causes uveitis. - In this study, sirolimus will be given as an injection under the outer layer of your eye. The FDA has permitted the investigational use of sirolimus for this study. Objectives: - To determine if subconjunctival injection of sirolimus is safe for treatment of uveitis. - To see if sirolimus is an effective treatment for uveitis.