MUST Competitive Renewal

必须有竞争力的更新

• 批准号: 8546002
• 负责人: MICHAEL M ALTAWEEL
• 金额: $ 2.85万
• 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/8546002
• 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; 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

DESCRIPTION (provided by applicant): 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 its complications. This resource center will participate in the design, conduct, analysis and reporting of the network studies. RELEVANCE: 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.

描述（由申请人提供）：中间、后和全葡萄膜炎是美国视力丧失和失明的主要原因。由于葡萄膜炎导致的视力丧失在青年期达到高峰，与年龄相关性眼病相比，葡萄膜炎导致的视力丧失对每例潜在视力丧失的影响更大。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，在选定的情况下辅以免疫抑制药物。NE！一项资助的MUST试验正在比较使用氟轻松眼内植入物与使用全身皮质类固醇和免疫抑制药物的标准治疗对此类患者的疗效和发病率。正在收集的有价值的数据将影响治疗选择。MUST 2试验将对该组进行另外6年的随访，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，并进一步指导慢性疾病的最佳管理。阿达木单抗是一种TNF抑制剂，可下调炎症性疾病的炎症反应，为治疗葡萄膜炎提供了一种新的潜在有效方法。一项方案将比较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疗效和发病率（眼部和全身）。葡萄膜炎中视力丧失的常见原因是黄斑水肿的发展。对视网膜血管疾病有效的治疗方法已被应用于葡萄膜炎相关性黄斑水肿的管理，但没有足够的证据支持其持续使用或长期安全性数据。两项试验将评估玻璃体内曲安西龙（Triessence）与标准subtenons曲安西龙的疗效和安全性，以及玻璃体内雷珠单抗与玻璃体内曲安西龙治疗葡萄膜炎性黄斑水肿的疗效和安全性。这将是第一个随机试验，以适当地指导我们进一步管理这一共同的临床实体。该应用程序支持创建一个研究网络，其中包括一个阅读中心，能够客观评估葡萄膜炎及其并发症引起的眼部形态学变化。该资源中心将参与网络研究的设计、实施、分析和报告。 相关性：葡萄膜炎是视力损害的主要原因，需要全身和/或眼部治疗的长期治疗，这可能会导致严重的发病率。设计用于改善结果同时限制不良反应的较新治疗包括fluocinilone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。