Pilot: Sunitinib Malate for Advance Ocular Disease of Von Hippel-Lindau Syndrome

苹果酸苏尼替尼治疗晚期Von Hippel-Lindau综合征眼病的初步研究 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： 这项研究将确定一种名为苹果酸舒尼替尼(Sutent)的实验性药物是否有助于减缓或阻止冯·希佩尔-林道(VHL)综合征患者眼部血管瘤(血管的异常生长)的生长。VHL是一种遗传性疾病，它会增加体内称为血管内皮生长因子(VEGF)和血小板衍生生长因子(PDGF)的化学物质的产生，这两种物质在新血管的形成中起着重要作用。

Pilot Study of Sunitinib Malate for Advanced Ocular Disease of Von Hippel-Lindau Syndrome 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 determine if an experimental drug called sunitinib malate (Sutent) can help slow or stop the growth of eye angiomas (abnormal growth of blood vessels) in people with Von Hippel-Lindau (VHL) syndrome. VHL is a genetic disorder that increases production of body chemicals called vascular endothelial growth factor (VEGF) and platelet derived growth factor (PDGF), which are important in the formation of new blood vessels.