Multicenter Uveitis Steroid Treatment (MUST) Trial

多中心葡萄膜炎类固醇治疗 (MUST) 试验

• 批准号: 6922758
• 负责人: Douglas A Jabs
• 金额: $ 35.96万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-15 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6922758
• 关键词: bioimaging /biomedical imaging; clinical research; clinical trials; cooperative study; corticosteroids; eye fundus photography; fluorescein angiography; hormone therapy; human subject; human therapy evaluation; image processing; implant; longitudinal human study; medical complication; medical implant science; optical tomography; outcomes research; patient oriented research; retinography; steroid hormone; uveitis

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.

描述(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，这些疾病在美国是导致视力丧失和失明的主要原因。葡萄膜炎可以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)的形式与高视力损失率有关。由于葡萄膜炎的发病高峰期是在青壮年，与年龄相关的眼病相比，葡萄膜炎导致的视力丧失对每个病例的潜在视力损失的影响将不成比例地更大。由于大多数中间葡萄膜炎、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，并在特定情况下辅以免疫抑制药物。尚未在葡萄膜炎领域进行由美国国立卫生研究院资助的大规模多中心临床试验或流行病学研究；因此，关于治疗结果的长期数据有限。氟喹诺酮丙酮眼内植入物是最近开发的一种通过手术植入的皮质类固醇储存库，设计持续三年，以提供对葡萄膜炎的长期控制。由于该植入物有可能以最小的全身副作用有效控制葡萄膜炎，因此该植入物的使用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、对照的临床试验--多中心葡萄膜炎类固醇治疗(MUST)试验，该试验将对患有严重的、威胁视力的中间葡萄膜炎、后葡萄膜炎或全葡萄膜炎患者的氟康奈德植入剂与标准疗法进行比较。根据标准化指南，活动期葡萄膜炎患者将被随机分成两组，要么接受氟康奈德植入剂治疗，要么接受由口服皮质类固醇和补充免疫抑制药物组成的“标准治疗”。设计结果将是视觉敏锐度结果。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)的缓解，以及由于疾病和治疗而导致的眼睛和全身并发症。其他好处包括关于葡萄膜炎的长期结果、其并发症、系统治疗葡萄膜炎的结果以及治疗并发症的前瞻性流行病学数据。