Microplasmin Intravitreal Administration in Patients with Uveitic Macular Edema

葡萄膜炎性黄斑水肿患者玻璃体内注射微纤溶酶

• 批准号: 8175487
• 负责人: DARBY THOMPSON
• 金额: $ 5.44万
• 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/8175487
• 关键词: Acquired Immunodeficiency Syndrome; Ambulatory Care Facilities; Antibiotics; Area Analyses; Back; Blindness; Blood Tests; Case-Control Studies; Clinical Protocols; Clinical Research; Clinical Trials; Collection; Contractor; Data; Databases; Diabetic Retinopathy; Early treatment; Economics; Epidemiology; Evaluation; Extramural Activities; Eye; Eye Part; Eye diseases; Eyedrops; Fluorescein Angiography; Healthcare; Hour; Image; Immune system; Inflammatory; Injection of therapeutic agent; Intramural Research; Medical History; Medicare; Monitor; National Eye Institute; Natural History; Operative Surgical Procedures; Ophthalmic examination and evaluation; Outcomes Research; Participant; Patients; Pharmaceutical Preparations; Proteins; Quality-of-Life Assessment; Research; Research Design; Research Personnel; Retina; Safety; Secondary to; Specific qualifier value; Support Contracts; Swelling; Testing; Time; Ultrasonography; Urine; Uveitis; Vision Disorders; Visit; Work; cost effectiveness; data management; design; effective therapy; follow-up; interest; macular edema; patient safety; preclinical study; prevent

Microplasmin Intravitreal Administration in Participants with Uveitic 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: - Uveitis is a serious inflammatory condition in which the body's immune system attacks parts of the eye, often causing vision loss. Some people with uveitis also have macular edema (swelling of the retina at the back of the eye). Uveitis and macular edema are treated with medications and sometimes surgery, but in many people treatment does not prevent vision loss. - Research has shown that injection of the lab-made protein microplasmin into the eye of people with eye disease other than uveitis can help treat macular edema and can slow visual loss. Microplasmin has not been approved to treat uveitis; however, researchers are interested in determining if it can be a safe and effective treatment for macular edema related to uveitis. Objectives: - To investigate the safety, tolerability and potential efficacy of an intravitreal injection of microplasmin as a possible treatment for macular edema secondary to uveitis.

葡萄膜炎性黄斑水肿患者玻璃体内注射微纤溶酶 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： - 葡萄膜炎是一种严重的炎症性疾病，身体的免疫系统会攻击眼睛的某些部位，通常会导致视力丧失。一些患有葡萄膜炎的人还患有黄斑水肿（眼睛后部的视网膜肿胀）。葡萄膜炎和黄斑水肿可以通过药物治疗，有时也可以通过手术治疗，但对许多人来说，治疗并不能防止视力丧失。 - 研究表明，将实验室制造的蛋白微纤溶酶注射到患有葡萄膜炎以外的眼部疾病的人的眼睛中可以帮助治疗黄斑水肿，并可以减缓视力丧失。微纤溶酶尚未被批准用于治疗葡萄膜炎；然而，研究人员有兴趣确定它是否可以安全有效地治疗与葡萄膜炎相关的黄斑水肿。 目标： - 研究玻璃体内注射微纤溶酶作为继发于葡萄膜炎的黄斑水肿的可能治疗方法的安全性、耐受性和潜在功效。