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: 9113668
• 负责人: MICHAEL M ALTAWEEL
• 金额: $ 21.14万
• 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/9113668
• 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; Effectiveness; Eligibility Determination; Environment Design; Equipment; Equipment and supply inventories; Evaluation; Eye; Formulation; 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; 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觉丧失的最常见原因。该提案的目的是解决对Uveltic黄斑水肿治疗的两个关键问题：1）葡萄膜黄斑水肿的最佳初始治疗； 2）最佳治疗持续的黄斑水肿（即初始治疗后尚未解决的黄斑水肿）。区域皮质类固醇注射是治疗的主要手段 对于葡萄象黄斑水肿。但是，有不同的途径和配方，这些途径和公式在试验中从未进行过比较，并且缺乏确定的试验导致临床实践中有很大的变化。对于持续的黄斑水肿，通常会重复注射皮质类固醇。然而，玻璃体内甲氨蝶呤和玻璃体内ranibizumab（Lucentis）的试验性研究提出了功效，可能比皮质固醇注射剂具有更少的眼部副作用，尽管在Ranibizumabs的情况下，可能具有更频繁的注射。没有对这些方法进行比较试验。现有的必须研究组基础设施将被利用，以进行两项对葡萄膜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）o比较眼周周围的曲安赛乙酰胺，玻璃体内三秒乙醇酮乙醇（Triescence）和玻璃体内地塞米松植入物（Ozurdex）的相对有效性； 2）比较玻璃体内ranibizumab（lucentis）和玻璃体内甲氨蝶呤与玻璃体内地塞米松植入物（Ozurdex）的相对有效性，用于治疗玻璃体内三体霉素注射后持续存在的葡萄膜黄斑水肿。阅读中心已经设计和精致的分级程序，用于评估在整个必不可少的研究中，并开发了创新的分析软件，尽管测量工具的差异有所不同，但仍可以整合来自所有研究地点的数据。形态学发现对于确定资格，治疗决策和关键终点很重要，有助于确定所研究的各种治疗方式的相对疗效和安全性。 相关性：葡萄膜炎与高视觉损失率有关，通常是由结构并发症引起的，而葡萄膜黄斑水肿是最常见的。此外，黄斑水肿是葡萄膜炎患者视觉丧失的最常见原因。提出的两项比较有效性试验将为指导临床医生进行葡萄象黄斑水肿的管理提供证据基础。