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: 8927647
• 负责人: Douglas A Jabs
• 金额: $ 35.09万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 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/8927647
• 关键词: Address; Adrenal Cortex Hormones; Adverse effects; Anti-Inflammatory Agents; Anti-inflammatory; Antimetabolites; Blindness; Cataract; Clinical; Clinical Treatment; Clinical Trials; Comparative Study; Complication; Dexamethasone; Disease; Drug Formulations; Edema; Effectiveness; Eye; Fibroblast Growth Factor; Glaucoma; Goals; Implant; Inflammation; Injection of therapeutic agent; Lucentis; Membrane; Methotrexate; Participant; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Pilot Projects; Randomized Clinical Trials; Relative (related person); Research; Research Infrastructure; 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; follow-up; improved; inhibitor/antagonist; intravitreal injection; macular edema; ranibizumab; 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 uveitic 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 uveitic 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 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 uveitic 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 uveitic macular edema; and 2) to compare the relative effectiveness of intravitreal ranibizumab (Lucentis), intravitreal methotrexate, and the intravitreal dexamethasone implant (Ozurdex) for the treatment of uveitic macular edema that persists after intravitreal triamcinolone injections. The results of these trials will guide clinicians regarding the best approaches for management of uveitic 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. 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。虽然有多种方法来治疗葡萄膜炎性黄斑水肿，没有比较试验，这些治疗已经进行。该提案的目标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;和2）持续性黄斑水肿的最佳治疗（即，初始治疗后未消退的黄斑水肿）。局部皮质类固醇注射是葡萄膜炎性黄斑水肿的主要治疗方法。然而，有不同的途径和制剂，从未在试验中进行过比较，缺乏明确的试验导致临床实践中存在相当大的差异。或持续性黄斑水肿时，通常给予皮质类固醇的重复注射。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（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）、玻璃体内甲氨蝶呤和玻璃体内地塞米松植入物（Ozurdex）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。这些试验的结果将指导临床医生关于葡萄膜炎性黄斑水肿的最佳管理方法。MUST研究小组是唯一适合解决这些问题的基础上，其专业知识的广度和良好的跟踪记录，证明了成功完成的MUST试验和正在进行的MUST随访研究的参与者在MUST试验。 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。