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，流行病学和自然史研究的校外支持。此外，它将提供涉及眼科疾病和视觉障碍的结果研究以及一些临床前研究。重点应放在研究的设计和收集，分析和解释这些研究产生的数据，以及支持和监测患者的安全性和随访。承包商还应提供工作说明书中所述的分析和数据管理支持，用于指定的临床研究数据库、成本效益和经济分析、生活质量评估和结局研究。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，例如集中的NEI校内研究数据库、眼部疾病病例对照研究、早期治疗糖尿病视网膜病研究、弗雷明汉眼科研究以及校内艾滋病和葡萄膜炎数据库。 临床方案的目的： - 糖尿病视网膜病变，或眼睛后部小血管的损伤，是糖尿病的常见并发症，并且是失明的主要原因。糖尿病视网膜病变会导致眼睛肿胀，称为糖尿病黄斑水肿，导致视力丧失。 - 慢性炎症与糖尿病性黄斑水肿有关。小胶质细胞是视网膜中参与视网膜炎症的细胞。由于这些原因，小胶质细胞代表了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的有希望的细胞靶点。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。研究人员有兴趣研究米诺环素是否可用于治疗或减缓糖尿病黄斑水肿的进展。 目的： - 观察米诺环素治疗糖尿病性黄斑水肿的安全性和有效性。

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.