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: 8996746
• 负责人: Janet T. Holbrook
• 金额: $ 0.99万
• 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/8996746
• 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; Drug Formulations; Effectiveness; Epiretinal Membrane; Eye; Fibroblast Growth Factor; Glaucoma; Goals; Implant; Inflammation; Injection of therapeutic agent; Lucentis; Methotrexate; Participant; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Pilot Projects; Randomized Clinical Trials; Relative (related person); 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; 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 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. RELEVANCE: Uveitis is associated with high rates of visual loss, typically caused by structural complications, of which uveitis 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 uveitis 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。尽管有多种方法可以治疗黄斑水肿，但尚未对这些治疗进行比较试验。该提案的目的是解决葡萄炎黄斑水肿治疗的两个关键问题：1）葡萄膜炎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葡萄膜炎的主要治疗葡萄膜水肿。但是，有不同的途径和配方，这些途径和公式从未在试验中进行过比较，并且缺乏确定的试验导致临床实践的差异很大。或持续的黄斑水肿，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，以进行两项比较有效性临床试验，以治疗葡萄膜炎黄斑水肿。试验的具体目的是：1）比较眼周周围曲安西酮乙烯胺，玻璃体内triamcinolone乙烯酰胺（Triesence）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的相对有效性与玻璃体内地塞米松植入物（Ozurdex）治疗葡萄膜炎的葡萄膜性水肿，这些植入术后玻璃体内三体霉素注射后持续存在。这些试验的结果将指导临床医生关于葡萄膜炎的最佳方法。必不可少的研究小组非常适合根据其专业知识的广度和经过验证的记录来解决这些问题，这是通过成功完成必须审判的成功证明的，并且必须通过不断进行的必须对参与者进行必不可少的审判。 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，葡萄膜炎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在葡萄膜炎的管理中提供证据基础。