Intravitreal Inj of Ranibizumab for Macular Telangiectasia w/o Neovascularization

玻璃体内注射雷珠单抗治疗黄斑毛细血管扩张症（无新生血管）

• 批准号: 8075874
• 负责人: DARBY THOMPSON
• 金额: $ 4.31万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-11-01 至 2011-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8075874
• 关键词: Acquired Immunodeficiency Syndrome; Age related macular degeneration; Area Analyses; Back; Blindness; Blood Vessels; Case-Control Studies; Chemicals; Clinical Research; Clinical Trials; Collection; Contractor; Contracts; Data; Databases; Diabetic Retinopathy; Disease; Early treatment; Economics; Epidemiology; Evaluation; Extramural Activities; Eye; Eye diseases; Healthcare; Injection of therapeutic agent; Intramural Research; Lucentis; Medicare; Monitor; Natural History; Outcomes Research; Pharmaceutical Preparations; Pilot Projects; Quality-of-Life Assessment; Research Design; Retina; Specific qualifier value; Telangiectasis; Uveitis; Vascular Endothelial Growth Factors; Vision Disorders; Work; cost effectiveness; data management; design; eye blood vessel; follow-up; macula; neovascularization; patient safety; preclinical study; prevent; ranibizumab

Pilot Study of Intravitreal Injection of Ranibizumab for Macular Telangiectasia without Neovascularization (MACTEL 2) 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 examine whether the drug ranibizumab (Lucentis) can help prevent vision loss in people with macular telangiectasia, a condition in which new blood vessels grow in the retina at the back of the eye and can leak. Such changes in blood vessels are seen in other diseases associated with changes in a body chemical called vascular endothelial growth factor (VEGF). Ranibizumab is an anti-VEGF drug that is effective in treating another eye disease, age-related macular degeneration, with similar changes in eye blood vessels.

玻璃体内注射雷珠单抗治疗无新生血管的黄斑毛细血管扩张症的初步研究（MACTEL 2） 临床方案支持合同旨在为开发、设计、解释和评估临床试验、流行病学和自然史研究获得外部支持。此外，还将提供涉及眼部疾病和视觉障碍的结果研究以及一些临床前研究。重点应放在研究设计以及这些研究数据的收集、分析和解释，以及支持和监测患者安全和随访上。承包商还应为指定的临床研究数据库、成本效益和经济分析、生活质量评估和结果研究提供工作说明书中所述的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；评估现有的 NEI 数据库，例如中央 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、弗雷明汉眼科研究以及校内艾滋病和葡萄膜炎数据库。 临床方案的目标： 这项研究将检验药物雷珠单抗（Lucentis）是否可以帮助预防黄斑毛细血管扩张症患者的视力丧失，黄斑毛细血管扩张症是一种新血管在眼睛后部视网膜中生长并可能渗漏的疾病。这种血管变化也可见于与体内化学物质血管内皮生长因子 (VEGF) 变化相关的其他疾病。雷珠单抗是一种抗 VEGF 药物，可有效治疗另一种眼部疾病——年龄相关性黄斑变性，眼部血管也有类似的变化。