Multicenter Uveitis Steroid Treatment (MUST) Trial

描述（由申请人提供）：葡萄膜炎是指几种以眼内炎症为特征的眼部疾病，在美国，这些疾病是导致视力丧失和失明的主要原因。葡萄膜炎可影响眼睛的任何部位；那些主要影响玻璃体（中间葡萄膜炎）、视网膜和脉络膜（后葡萄膜炎）或整个眼睛（全葡萄膜炎）的形式与视力丧失的高发率有关。由于葡萄膜炎的发病高峰是在年轻的成年期，由于葡萄膜炎导致的视力丧失对每个病例的潜在视力丧失年数的影响将比与年龄相关的眼病大得多。由于大多数中度葡萄膜炎、后葡萄膜炎和全葡萄膜炎是慢性的，治疗需要长期治疗。目前对严重、威胁视力的葡萄膜炎患者的治疗通常包括使用全身药物，主要是口服皮质类固醇，在特定情况下辅以免疫抑制药物。没有在葡萄膜炎领域进行大规模的、NIH资助的、多中心的临床试验或流行病学研究；因此，关于治疗结果的长期数据是有限的。醋酸氟西诺酮眼内植入物是最近开发的一种手术植入的皮质类固醇储存库，旨在持续三年，以提供对葡萄膜炎的长期控制。由于具有有效控制葡萄膜炎的潜力和最小的全身副作用，使用这种植入物可能会改变葡萄膜炎的治疗方式。因此，提出了一项多中心、随机、对照临床试验，即多中心葡萄膜炎类固醇治疗（MUST）试验，该试验将氟西诺酮植入物与“标准疗法”比较，用于治疗严重的、威胁视力的中间、后或全葡萄膜炎患者。根据标准化指南，活动性葡萄膜炎患者将随机接受氟西诺酮植入治疗或“标准治疗”，包括口服皮质类固醇和补充免疫抑制药物。设计结果将是视力结果。其他结果包括控制葡萄膜炎的能力，黄斑水肿（这些患者视力丧失的主要原因）的消退，疾病和治疗引起的眼部和全身发病率。其他益处包括关于葡萄膜炎长期结局、并发症、葡萄膜炎全身治疗结局和治疗并发症的前瞻性流行病学数据。

DESCRIPTION (provided by applicant): Uveitis refers to several ocular disorders characterized by intraocular inflammation, which in the aggregate are major causes of visual loss and blindness in the United States. Uveitis may affect any part of the eye; those forms affecting primarily the vitreous (intermediate uveitis), the retina and choroid (posterior uveitis), or the entire eye (panuveitis) are associated with high rates of visual loss. Because the peak onset of uveitis is in young adulthood, vision loss due to uveitis will have a disproportionately greater impact on years of potential vision lost per case than age-related eye diseases. Because most cases of intermediate uveitis, posterior uveitis, and panuveitis are chronic, treatment requires long-term therapy. Current therapy for patients with severe, vision-threatening uveitis typically involves the use of systemic medications, primarily oral corticosteroids, supplemented by immunosuppressive drugs in selected situations. No large-scale, NIH funded, multicenter clinical trials or epidemiologic studies have been performed in the area of uveitis; therefore, long-term data on the outcomes of treatment are limited. The fluocinolone acetonide intraocular implant is a recently-developed, surgically implanted reservoir of corticosteroid designed to last three years in order to provide long-term control of uveitis. Because of the potential for effective control of uveitis with minimal systemic side effects, the use of this implant may alter the way in which uveitis is treated. Therefore, a multicenter, randomized, controlled clinical trial, the Multicenter Uveitis Steroid Treatment (MUST) trial, is proposed, which will compare the fluocinolone acetonide implant to "standard therapy" for the treatment of patients with severe, vision-threatening intermediate, posterior, or panuveitis. Patients with active uveitis will be randomized to treatment with either the fluocinolone acetonide implant or "standard therapy" consisting of oral corticosteroids and supplementary immunosuppressive drugs when indicated, according to standardized guidelines. The design outcome will be visual acuity outcomes. Other outcomes include ability to control the uveitis, resolution of macular edema (a major cause of visual loss in these patients), and ocular and systemic morbidity from both the disease and the treatments. Additional benefits include prospective epidemiologic data on the long-term outcomes of uveitis, its complications, outcomes of systemic treatments for uveitis, and complications of the treatments.