Multicenter uveitis trial using a steroid implant and inflammatory mediators

葡萄膜炎指的是几种以眼内炎症为特征的眼部疾病，在美国，这些疾病加在一起是导致视力丧失和失明的主要原因。中间葡萄膜炎、后葡萄膜炎和全葡萄膜炎通常是更严重的葡萄膜炎，具有最高的视力丧失风险，通常需要长期的全身治疗。氟喹诺酮丙酮眼内植入物是一种通过手术植入的皮质类固醇储存库，设计寿命约为2.5年，以提供对葡萄膜炎的长期控制。 多中心葡萄膜炎类固醇治疗(MIME)试验的主要目标是比较标准化系统疗法和氟喹诺酮植入剂疗法治疗重症非感染性中间葡萄膜炎、后葡萄膜炎或全葡萄膜炎的疗效。根据标准化指南，活动期葡萄膜炎患者将按1：1的分配比例随机接受氟康奈德植入剂或由口服皮质类固醇和补充免疫抑制药物组成的标准化系统治疗。这项研究的设计结果变量是视力；其他结果包括视觉功能的其他方面、成功控制葡萄膜炎、视网膜形态结果、生活质量、成本效益以及潜在的葡萄膜炎和治疗的眼部和全身并发症的发生。

Uveitis refers to several ocular disorders characterized by intraocular inflammation, which in the aggregate are a major cause of visual loss and blindness in the United States. Intermediate uveitis, posterior uveitis, and panuveitis are generally the more severe forms of uveitis, with the highest risk of vision loss, often requiring long-term systemic treatment. The fluocinolone acetonide intraocular implant is a surgically implanted reservoir of corticosteroid designed to last approximately 2.5 years in order to provide long-term control of uveitis. The primary objective of the Multicenter Uveitis Steroid Treatment (MUST) Trial is to compare the efficacy of standardized systemic therapy versus fluocinolone acetonide implant therapy for the treatment of severe cases of non-infectious intermediate uveitis, posterior uveitis or panuveitis. Patients with active uveitis will be randomized, with a 1:1 allocation ratio, to treatment with either the fluocinolone acetonide implant or standardized systemic therapy consisting of oral corticosteroids and supplementary immunosuppressive drugs when indicated, according to standardized guidelines. The design outcome variable for the study is visual acuity; other outcomes include other aspects of visual function, success in controlling uveitis, retinal morphologic outcomes, quality of life, cost-effectiveness, and occurrence of potential ocular and systemic complications of uveitis and of therapy.