Minocycline as a Microglia Inhibitor in the Treatment of Diabetic Macular Edema

米诺环素作为小胶质细胞抑制剂治疗糖尿病黄斑水肿

• 批准号: 8175491
• 负责人: DARBY THOMPSON
• 金额: $ 0.7万
• 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/8175491
• 关键词: Acquired Immunodeficiency Syndrome; Ambulatory Care Facilities; Antibiotics; Area Analyses; Back; Blindness; Blood Glucose; Blood Tests; Blood Vessels; Blood flow; Caring; Case-Control Studies; Cells; Chronic; Clinical Protocols; Clinical Research; Clinical Trials; Collection; Complications of Diabetes Mellitus; Contractor; Data; Databases; Diabetic Retinopathy; Early treatment; Economics; Effectiveness; Enrollment; Epidemiology; Evaluation; Extramural Activities; Eye; Eye diseases; Follow-Up Studies; Healthcare; Hour; Inflammation; Inflammatory; Intramural Research; Lasers; Lead; Measures; Medicare; Microglia; Minocycline; Monitor; National Eye Institute; Natural History; Ophthalmic examination and evaluation; Ophthalmologist; Outcomes Research; Participant; Patients; Pharmaceutical Preparations; Pilot Projects; Quality-of-Life Assessment; Research Design; Research Personnel; Retina; Retinal; Specific qualifier value; Support Contracts; Swelling; Tablets; Testing; Thick; Uveitis; Vision Disorders; Visit; Visual; Visual Acuity; Work; cellular targeting; cost effectiveness; data management; design; diabetic; follow-up; inhibitor/antagonist; interest; macular edema; patient safety; preclinical study; safety testing

A Pilot Study for the Evaluation of Minocycline as a Microglia Inhibitor 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: - Diabetic retinopathy, or damage to the small blood vessels at the back of the eye, is a frequent complication of diabetes, and is a leading cause of blindness. Diabetic retinopathy can lead to swelling within the eye, known as diabetic macular edema which causes vision loss. - Chronic inflammation has been implicated in diabetic macular edema. Microglia are cells in the retina involved in inflammation in the retina. For these reasons, microglia represent a promising cellular target for forms of therapy that limit the harmful inflammatory changes found in diabetic retinopathy. Minocycline, a drug that is currently approved for use as an antibiotic, may be able to inhibit microglia and thus reduce their contribution to chronic inflammation. Researchers are interested in examining whether minocycline may be used to treat or slow the progress of diabetic macular edema. Objectives: - To test the safety and effectiveness of minocycline as a treatment for diabetic macular edema.

米诺环素作为小胶质细胞抑制剂治疗糖尿病黄斑水肿的初步研究 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： -糖尿病视网膜病变，或眼后小血管受损，是糖尿病的常见并发症，也是导致失明的主要原因。糖尿病视网膜病变可导致眼内肿胀，称为糖尿病黄斑水肿，导致视力丧失。 -糖尿病黄斑水肿与慢性炎症有关。小胶质细胞是视网膜中参与视网膜炎症的细胞。出于这些原因，小胶质细胞是一种有希望的细胞靶点，可用于限制糖尿病视网膜病变中发现的有害炎症变化的治疗形式。米诺环素是一种目前被批准用作抗生素的药物，它可能能够抑制小胶质细胞，从而减少它们对慢性炎症的贡献。研究人员感兴趣的是研究米诺环素是否可以用于治疗或减缓糖尿病黄斑水肿的进展。 目标： -测试米诺环素治疗糖尿病黄斑水肿的安全性和有效性。