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: 9211348
• 负责人: Janet T. Holbrook
• 金额: $ 192.29万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 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 2020-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9211348
• 关键词: Address; Adrenal Cortex Hormones; Adverse effects; Anti-Inflammatory Agents; Anti-inflammatory; Antimetabolites; Blindness; Cataract; Choroidal Neovascularization; Clinical; Clinical Treatment; Clinical Trials; Comparative Study; Complication; Dexamethasone; Disease; Epiretinal Membrane; Eye; Follow-Up Studies; Formulation; Glaucoma; Goals; Growth Factor; Implant; Inflammation; Injection of therapeutic agent; Lucentis; Methotrexate; Participant; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Pilot Projects; Randomized Clinical Trials; Research; Research Infrastructure; Retinal Neovascularization; Route; San Francisco; Triamcinolone; Triamcinolone Acetonide; Uveitis; Vascular Endothelial Cell; Visual Acuity; base; clinical practice; comparative effectiveness; comparative trial; cost effective; effectiveness clinical trial; effectiveness trial; evidence base; improved; inhibitor/antagonist; intravitreal injection; macular edema; ranibizumab; relative effectiveness; success; treatment trial

DESCRIPTION (provided by applicant): Macular edema is the most common cause of visual loss among patients with uveitis. Although there are multiple approaches to the treatment of uveitis macular edema, no comparative trials of these treatments have been performed. The goal of this proposal is to address two critical issues in the treatment of uveitis macular edema: 1) the optimal initial treatment for uveitis 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 uveitis 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 variability in clinical practice. or 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 uveitis macular edema. The specific aims of the trials are: 1) to compare the relative effectiveness of periocular triamcinolone acetonide, intravitreal triamcinolone acetonide (Triescence), and the intravitreal dexamethasone implant (Ozurdex) for the treatment of uveitis 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 uveitis macular edema that persists after intravitreal triamcinolone injections. The results of these trials will guide clinicians regarding the best approaches for management of uveitis macular edema. The MUST Research Group is uniquely suited to address these issues based upon both its breadth of expertise and proven track record, demonstrated by the successful completion of the MUST Trial and by the ongoing MUST Follow-up Study of participants in the MUST Trial.

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。虽然有多种治疗葡萄膜炎黄斑水肿的方法，但没有进行这些治疗的比较试验。本提案的目的是解决两个关键问题在治疗葡萄膜炎黄斑水肿：1)葡萄膜炎黄斑水肿的最佳初始治疗；2)持续性黄斑水肿（即初始治疗后仍未消退的黄斑水肿）的最佳治疗方法。局部皮质类固醇注射是治疗葡萄膜炎黄斑水肿的主要方法。然而，有不同的途径和配方，从未在试验中进行比较，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，通常需要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尼珠单抗（Lucentis）的初步研究表明，其疗效可能比皮质类固醇注射更少，尽管雷尼珠单抗可能需要更频繁的注射。没有对这些方法进行比较试验。现有的MUST研究小组基础设施将被利用来进行两项治疗葡萄膜炎黄斑水肿的比较有效的临床试验。这些试验的具体目的是：1)比较眼周曲安奈德、玻璃体内曲安奈德（Triescence）和玻璃体内地塞米松植入物（Ozurdex）治疗葡萄膜炎黄斑水肿的相对疗效；2)比较玻璃体内注射雷尼单抗（Lucentis）和玻璃体内甲氨蝶呤与玻璃体内地塞米松植入物（Ozurdex）治疗玻璃体内注射曲安奈德后持续存在的葡萄膜炎黄斑水肿的相对有效性。这些试验的结果将指导临床医生关于管理葡萄膜炎黄斑水肿的最佳方法。MUST研究小组是唯一适合解决这些问题的，基于其广泛的专业知识和可靠的跟踪记录，证明了MUST试验的成功完成和正在进行的MUST试验参与者的随访研究。