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

西罗莫司治疗糖尿病性黄斑水肿的初步评价 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，流行病学和自然史研究的校外支持。此外，它将提供涉及眼科疾病和视觉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收集，分析和解释这些研究产生的数据，以及支持和监测患者的安全性和随访。承包商还应提供工作说明书中所述的分析和数据管理支持，用于指定的临床研究数据库、成本效益和经济分析、生活质量评估和结局研究。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;现有NEI数据库的评估，如集中的NEI校内研究数据库，眼病病例对照研究，早期治疗糖尿病视网膜病变研究，Fracket Eye研究，以及校内艾滋病和葡萄膜炎数据库。 临床方案的目的： 这项研究将测试西罗莫司，一种被批准用于治疗银屑病和其他疾病的药物，是否可以帮助糖尿病黄斑水肿患者。在这种疾病中，视网膜（眼睛后部的一层薄薄的组织）中的血管变得渗漏，视网膜肿胀。黄斑是视网膜的中心部分，负责精细的视力，也可能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，该蛋白质在调节细胞如何分裂和生长方面起着关键作用。西罗莫司也被认为影响炎症过程。由于这两个原因，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