Macular Edema Treatment Trials Associated with MUST (META-MUST)

与 MUST 相关的黄斑水肿治疗试验 (META-MUST)

• 批准号: 8927648
• 负责人: MICHAEL M ALTAWEEL
• 金额: $ 20.1万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-30 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8927648
• 关键词: Address; Adrenal Cortex Hormones; Adverse effects; Anti-Inflammatory Agents; Anti-inflammatory; Blindness; Certification; Chairperson; Clinical Trials; Collaborations; Complication; Computer software; Controlled Environment; Data; Data Coordinating Center; Dexamethasone; Drug Formulations; Effectiveness; Eligibility Determination; Environment Design; Equipment; Equipment and supply inventories; Evaluation; Eye; Fundus; Goals; Image; Implant; Injection of therapeutic agent; Internet; Leadership; Legal Blindness; Lens Opacities; Lucentis; Masks; Measurement; Methotrexate; Modality; Monitor; Morphology; Optical Coherence Tomography; Outcome; Outcome Measure; Patients; Physical shape; Pilot Projects; Preparation; Principal Investigator; Program Evaluation; Protocols documentation; Publications; Quality Control; Randomized; Reading; Relative (related person); Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Retinal; Route; Safety; San Francisco; Site; Steroids; Thick; Training; Triamcinolone; Triamcinolone Acetonide; Universities; Uveitis; Variant; Visual Acuity; Visual impairment; Wisconsin; Writing; clinical practice; clinical research site; comparative effectiveness; comparative trial; data integration; design; effective therapy; effectiveness clinical trial; effectiveness trial; evidence base; image archival system; innovation; instrument; lens; macular edema; primary outcome; ranibizumab; treatment trial

DESCRIPTION (provided by applicant): Macular edema is the most common cause of visual loss among patients with uveitis. The goal of this proposal is to address two critical issues in th treatment of uveltic macular edema: 1) the optimal initial treatment for uveitic macular edema; and 2) the optimal treatment of persistent macular edema (i.e. macular edema that has not resolved after initial treatment). Regional corticosteroid injections are the mainstay of treatment for uveitic macular edema. However, there are different routes and formulations, which never have been compared in a trial, and the lack of definitive trials has led to considerable variabilit in clinical practice. For persistent macular edema, repeat injections of corticosteroids typically are administered. However, pilot studies of intravitreal methotrexate and of intravitreal ranibizumab (Lucentis) have suggested efficacy, possibly with fewer ocular side effects than corticosteroid injections, although in the case of ranibizumab possibly with more frequent injections. No comparative trials have been performed of these approaches. The existing MUST Research Group infrastructure will be leveraged to perform two comparative effectiveness clinical trials on the treatment of uveitic macular edema. The specific aims of the trials are: 1) o compare the relative effectiveness of periocular triamcinolone acetonide, intravitreal triamcinolone acetonide (Triescence), and the intravitreal dexamethasone implant (Ozurdex) for the treatment of uveitic macular edema; and 2) to compare the relative effectiveness of intravitreal ranibizumab (Lucentis) and intravitreal methotrexate to the intravitreal dexamethasone implant (Ozurdex) for the treatment of uveitic macular edema that persists after intravitreal triamcinolone injections. The Reading Center has devised and refined grading programs for evaluation of uveitic macular edema throughout the MUST studies and has developed innovative analysis software that will allow integration of data from all study sites despite variation in measurement instruments. Morphologic findings are important for eligibility determination, treatment decisions, and critical endpoints that assist in determining relative efficacy and safety of the various treatment modalities being studied. RELEVANCE: Uveitis is associated with high rates of visual loss, typically caused by structural complications, of which uveitic macular edema is among the most common. Furthermore, macular edema is the most frequent cause of visual loss among patients with uveitis. The two proposed comparative effectiveness trials will provide an evidence base to guide clinicians in the management of uveitic macular edema.

描述（由申请人提供）：黄斑水肿是葡萄膜炎患者视力丧失的最常见原因。本提案的目的是解决葡萄膜炎性黄斑水肿治疗中的两个关键问题：1）葡萄膜炎性黄斑水肿的最佳初始治疗;以及2）持续性黄斑水肿（即初始治疗后未消退的黄斑水肿）的最佳治疗。局部皮质类固醇注射是治疗的主要手段 治疗葡萄膜炎性黄斑水肿然而，有不同的途径和制剂，从未在试验中进行过比较，并且缺乏明确的试验导致临床实践中存在相当大的差异。对于持续性黄斑水肿，通常重复注射皮质类固醇。然而，玻璃体内甲氨蝶呤和玻璃体内雷珠单抗（Lucentis）的初步研究表明了疗效，可能比皮质类固醇注射具有更少的眼部副作用，尽管在雷珠单抗的情况下可能具有更频繁的注射。尚未对这些方法进行比较试验。现有的MUST研究组基础设施将被用来进行两项关于葡萄膜炎性黄斑水肿治疗的比较有效性临床试验。试验的具体目的是：1）比较眼周曲安奈德、玻璃体内曲安奈德的相对有效性（Triescence）和玻璃体内地塞米松植入物（Ozurdex）用于治疗葡萄膜炎性黄斑水肿;和2）比较玻璃体内注射雷珠单抗的相对有效性（Lucentis）和玻璃体内甲氨蝶呤与玻璃体内地塞米松植入物（Ozurdex）相比，用于治疗玻璃体内曲安西龙注射后持续存在的葡萄膜炎性黄斑水肿。阅读中心已经设计并完善了MUST研究中葡萄膜炎性黄斑水肿评估的分级程序，并开发了创新的分析软件，该软件将允许整合所有研究中心的数据，尽管测量仪器存在差异。形态学结果对于合格性确定、治疗决策和关键终点非常重要，有助于确定正在研究的各种治疗方式的相对疗效和安全性。 相关性：葡萄膜炎与高比率的视力丧失相关，通常由结构性并发症引起，其中葡萄膜炎性黄斑水肿是最常见的。此外，黄斑水肿是葡萄膜炎患者中视力丧失的最常见原因。这两项拟议的疗效比较试验将为指导临床医生治疗葡萄膜炎性黄斑水肿提供证据基础。