Study of Evaluation of Sirolimus in the Treatment of Diabetic Macular Edema

西罗莫司治疗糖尿病黄斑水肿的初步研究 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： 这项研究将测试西罗莫司，一种被批准用于治疗牛皮癣和其他疾病的药物，是否可以帮助患有糖尿病黄斑水肿的患者。在这种疾病中，视网膜中的血管(排列在眼睛后部的一层薄薄的组织)变得渗漏，视网膜肿胀。黄斑是视网膜的中心部分，负责精细视力，也可能会肿胀并导致视力丧失。西罗莫司抑制体内一种名为mTOR的蛋白质，这种蛋白质在调节细胞分裂和生长方面发挥着关键作用。西罗莫司也被认为影响炎症过程。出于这两个原因，该药物可能有助于治疗糖尿病黄斑水肿。

Pilot Study of the Evaluation of Sirolimus in the Treatment of Diabetic Macular Edema 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: This study will test whether sirolimus, a drug approved to treat psoriasis and other conditions, can help patients with diabetic macular edema. In this disorder, blood vessels in the retina (a thin layer of tissue that lines the back of the eye) become leaky and the retina swells. The macula, the center part of the retina that is responsible for fine vision, may also swell and cause vision loss. Sirolimus inhibits a protein in the body called mTOR, which plays a critical role in regulating how cells divide and grow. Sirolimus is also believed to affect the inflammatory process. For both these reasons, the drug may be helpful in treating diabetic macular edema