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。尽管有多种治疗葡萄膜炎性黄斑水肿的方法，但尚未对这些治疗进行比较试验。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； 2) 持续性黄斑水肿（即初始治疗后尚未消退的黄斑水肿）的最佳治疗。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，存在不同的途径和制剂，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。或持续性黄斑水肿，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雷珠单抗（Lucentis）的初步研究表明其疗效，可能比皮质类固醇注射具有更少的眼部副作用，尽管雷珠单抗可能需要更频繁的注射。尚未对这些方法进行比较试验。将利用现有的澳门科技大学研究小组基础设施，开展两项治疗葡萄膜炎性黄斑水肿的有效性比较临床试验。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 (Trithesis) 和玻璃体内地塞米松植入物 (Ozurdex) 治疗葡萄膜炎性黄斑水肿的相对有效性； 2) 比较玻璃体内雷珠单抗（Lucentis）、玻璃体内甲氨蝶呤和玻璃体内地塞米松植入物（Ozurdex）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的相对有效性。这些试验的结果将指导临床医生治疗葡萄膜炎性黄斑水肿的最佳方法。澳门科技大学研究小组凭借其广泛的专业知识和良好的业绩记录，特别适合解决这些问题，成功完成澳门科技大学试验以及正在进行的澳门科技大学试验参与者的后续研究就证明了这一点。 相关性：葡萄膜炎与高视力丧失率相关，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视力丧失的最常见原因。这两项拟议的有效性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。