Genotype-Phenotype of Patients with Plaquenil )-Induced Retinal Toxicity (ABCA4)

Plaquenil 诱导的视网膜毒性 (ABCA4) 患者的基因型-表型

• 批准号: 8175490
• 负责人: DARBY THOMPSON
• 金额: $ 0.75万
• 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/8175490
• 关键词: Acquired Immunodeficiency Syndrome; Anti-Inflammatory Agents; Anti-inflammatory; Area Analyses; Autoimmune Diseases; Blindness; Blood specimen; Case-Control Studies; Clinic; Clinical Protocols; Clinical Research; Clinical Trials; Collection; Contractor; Data; Databases; Diabetic Retinopathy; Early treatment; Economics; Epidemiology; Evaluation; Extramural Activities; Eye; Eye diseases; Family history of; Gene Mutation; Genes; Genotype; Healthcare; Hydroxychloroquine; Intramural Research; Lead; Lupus; Medicare; Monitor; National Eye Institute; Natural History; Ophthalmic examination and evaluation; Outcomes Research; Outpatients; Participant; Patients; Persons; Pharmaceutical Preparations; Phenotype; Protocols documentation; Quality-of-Life Assessment; Research Design; Research Personnel; Retina; Retinal; Rheumatoid Arthritis; Specific qualifier value; Support Contracts; Testing; Toxic effect; Trademark; Uveitis; Vision Disorders; Visit; Work; cost effectiveness; data management; design; follow-up; interest; patient safety; preclinical study

Genotype-Phenotype Study of Patients with Plaquenil(Registered Trademark)-Induced Retinal Toxicity, with Evaluation of the ABCA4 Gene 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: - Plaquenil (hydroxychloroquine) is an anti-inflammatory drug that is used to treat some autoimmune diseases such as lupus and rheumatoid arthritis. This drug can damage the retina by causing a condition called plaquenil-induced retinal toxicity, which may lead to vision loss. However, most people taking plaquenil do not develop this problem. Researchers are interested in studying whether differences in a person's genes explain why some people develop plaquenil-induced retinal toxicity while others do not. Objectives: - To investigate possible correlations between certain genes or genetic mutations and plaquenil-induced retinal toxicity.

普莱奎尼(注册商标)所致视网膜毒性的基因-表型研究及ABCA4基因的评估 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： -普莱奎尼(羟氯喹)是一种抗炎药，用于治疗一些自身免疫性疾病，如狼疮和类风湿性关节炎。这种药物可以通过引起一种称为斑块诱导的视网膜毒性的情况来损害视网膜，这可能会导致视力丧失。然而，大多数服用普鲁培尼的人不会出现这种问题。研究人员感兴趣的是，一个人的基因差异是否可以解释为什么有些人会患上斑块菌素诱导的视网膜毒性，而另一些人则不会。 目标： -调查某些基因或基因突变与斑块尼诱导的视网膜毒性之间的可能相关性。