MUST Competitive Renewal

必须有竞争力的更新

• 批准号: 8655155
• 负责人: MICHAEL M ALTAWEEL
• 金额: $ 21.24万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-15 至 2017-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8655155
• 关键词: Adrenal Cortex Hormones; Adverse effects; Angiography; Autoimmune Process; Blindness; Cataract; Characteristics; Choroidal Neovascularization; Chronic; Chronic Disease; Clinical; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Color; Data; Development; Disease; Effectiveness; Epidemiologic Studies; Epiretinal Membrane; Evaluation; Eye diseases; FDA approved; Feedback; Fluocinolone Acetonide; Fluorescein; Fluorescein Angiography; Funding; Fundus; Fundus photography; Glaucoma; Goals; Group Structure; Humira; Image; Image Analysis; Imaging Techniques; Immunosuppression; Immunosuppressive Agents; Implant; Inflammation; Inflammatory; Instruction; Laboratories; Leadership; Local Therapy; Lucentis; Modality; Monitor; Monoclonal Antibodies; Morbidity - disease rate; Optical Coherence Tomography; Oral; Outcome; Outcomes Research; Panuveitis; Patient Agents; Patients; Pharmaceutical Preparations; Pharmacotherapy; Phase; Pilot Projects; Preparation; Principal Investigator; Procedures; Process; Protocols documentation; Publications; Randomized Controlled Clinical Trials; Reaction; Reading; Relative (related person); Reporting; Research; Research Personnel; Resources; Retinal; Retinal Neovascularization; Safety; San Francisco; Scanning; Series; Severities; Steroids; Systemic Therapy; Training; Triamcinolone; Triamcinolone Acetonide; Tumor Necrosis Factor-alpha; United States; Universities; Uveitis; Vascular Diseases; Vascular Endothelial Growth Factors; Vision; Visual; Visual impairment; Wisconsin; adalimumab; age related; cohort; comparative efficacy; comparative trial; compare effectiveness; design; effective therapy; evidence base; follow-up; high risk; human monoclonal antibodies; improved; inhibitor/antagonist; lens; macular edema; novel; randomized trial; ranibizumab; research study; standard care; stereoscopic; therapy design; treatment trial; trial comparing; young adult

intermediate, posterior, and panuveitis are major causes of vision loss and blindness in the United States. With a peak onset in young adulthood, vision loss due to uveitis will have a greater impact on years of potential vision lost per case than age-related eye diseases. Most of these diseases are chronic and require long-term treatment. Current therapy typically involves the use of oral corticosteroids, supplemented by immunosuppressive drugs in selected situations. The NE! funded MUST trial is comparing the efficacy and morbidity associated with the use of fluocinolone acetonide intraocular implant versus standard therapy with systemic corticosteroids and immunosuppressive medications for such patients. Valuable data being gathered will influence treatment choices. The MUST 2 trial will follow this group for another 6 years, providing objective information regarding the long-term visual and morphologic effects of severe uveitis and further guidance regarding the best management for a chronic disorder. Adalimumab, a TNF inhibitor that downregulates the inflammatory reaction in inflammatory diseases, provides a novel and potentially effective approach to managing uveitis. One protocol will compare the efficacy and morbidity (ocular and systemic) of adalimumab versus corticosteroids and standard immunosuppression for severe uveitis. A common cause of vision loss in uveitis is the development of macular edema. Modalities of treatment found effective for retinal vascular disease have been applied to management of uveitis-related macular edema but do not have sufficient evidence to support their continued use or longterm data regarding safety. Two trials would evaluate the efficacy and safety of intravitreal triamcinolone (Triessence) versus standard subtenons triamcinolone, and intravitreal ranibizumab versus intravitreal triamcinolone for uveitic macular edema. These would be the first randomized trials to properly direct our further management of this common clinical entity. This application supports the creation of a study network that includes a Reading center capable of objectively assessing morphologic ocular changes due to uveitis and it's complications. This resource center will participate in the design, conduct, analysis and reporting of the network studies. RELEVANCE (See instructions): Uveitis is a major cause of visual impairment, requiring chronic treatment with systemic and/or ocular therapy that may induce significant morbidity. Newer treatments designed to improve outcome while limiting adverse effects include the fluocinilone implant, intravitreal steroids, intravitreal ranibizumab, and Adalimumab. Evidence supporting such treatments is limited. Randomized trials will elucidate appropriate management.

在美国，中间葡萄膜炎、后葡萄膜炎和全葡萄膜炎是视力丧失和失明的主要原因。 由于在青年期发病高峰，由于葡萄膜炎导致的视力丧失将对未来几年产生更大的影响。 潜在的视力损失比与年龄相关的眼病。这些疾病大多是慢性的，需要 长期治疗。目前的治疗通常涉及使用口服皮质类固醇，辅以 免疫抑制药物在特定情况下。NE！资助的MUST试验正在比较疗效和 使用氟轻松眼内植入物与标准治疗相关的发病率 全身性皮质类固醇和免疫抑制药物。有价值的数据 会影响治疗的选择。MUST 2试验将再跟踪这一组6年， 提供关于严重葡萄膜炎的长期视觉和形态学影响的客观信息， 关于慢性疾病最佳管理的进一步指导。阿达木单抗，一种TNF抑制剂， 下调炎症性疾病中的炎症反应，提供了一种新的和潜在有效的 治疗葡萄膜炎的方法。一项方案将比较以下药物的疗效和发病率（眼部和全身）： 阿达木单抗与皮质类固醇和标准免疫抑制剂治疗重度葡萄膜炎的比较。的常见原因 葡萄膜炎中的视力丧失是黄斑水肿的发展。视网膜病变的有效治疗方法 血管疾病已被应用于葡萄膜炎相关性黄斑水肿的管理， 有足够的证据支持其持续使用或长期安全性数据。两次审判将 评价玻璃体内注射曲安奈德（Triessence）与标准眼筋膜下注射的有效性和安全性 曲安奈德和玻璃体内雷珠单抗对比玻璃体内曲安奈德治疗葡萄膜炎性黄斑水肿。 这将是第一个随机试验，以正确指导我们进一步管理这一常见的临床 实体此应用程序支持创建一个学习网络，其中包括一个阅读中心， 客观评价葡萄膜炎及其并发症引起的眼部形态学改变。这个资源中心 将参与网络研究的设计、实施、分析和报告。 相关性（参见说明）： 葡萄膜炎是视力损害的主要原因，需要通过全身和/或眼部治疗进行长期治疗 可能导致严重的发病率。旨在改善结局同时限制不良反应的新治疗 作用包括氟西尼龙植入物、玻璃体内类固醇、玻璃体内雷珠单抗和阿达木单抗。 支持这种治疗的证据是有限的。随机试验将阐明适当的管理。