Macular Edema Treatment Trials Associated with MUST (META-MUST)

描述(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，但这些治疗方法还没有进行过比较试验。这项建议的目标是解决治疗黄斑葡萄膜炎水肿的两个关键问题：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。局部注射糖皮质激素是治疗葡萄膜炎黄斑水肿的主要方法。然而，有不同的路线和配方，从来没有在试验中进行比较，而且缺乏决定性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，通常重复注射皮质类固醇。然而，对玻璃体内注射甲氨蝶呤和玻璃体内雷尼比珠单抗(Lucentis)的初步研究表明了疗效，可能比皮质类固醇注射更少的眼部副作用，尽管在雷尼比珠单抗的情况下可能会更频繁地注射。还没有对这些方法进行对比试验。现有的必须研究集团的基础设施将被用来进行两项治疗葡萄膜炎黄斑水肿的比较有效性的临床试验。这些试验的具体目的是：1)比较曲安奈德、玻璃体内曲安奈德和地塞米松玻璃体内植入(Ozurdex)治疗黄斑葡萄膜炎的相对疗效；2)比较雷尼比单抗(Lucentis)和氨甲蝶呤玻璃体内注射与地塞米松玻璃体内植入(Ozurdex)治疗玻璃体内注射曲安奈德后持续的黄斑葡萄膜炎的相对疗效。这些试验的结果将指导临床医生治疗葡萄膜炎黄斑水肿的最佳方法。MAND研究小组凭借其广博的专业知识和可靠的记录，特别适合于解决这些问题，这一点从MARM试验的成功完成和正在进行的对MARM试验参与者的MUST后续研究中得到了证明。 相关性：葡萄膜炎与高视力丧失有关，通常由结构性并发症引起，其中葡萄膜炎黄斑水肿是最常见的并发症之一。此外，黄斑水肿是葡萄膜炎患者视力丧失的最常见原因。两项拟议的比较有效性试验将为指导临床医生治疗葡萄膜炎黄斑水肿提供证据基础。

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.