Multicenter uveitis trial using a steroid implant and inflammatory mediators

使用类固醇植入物和炎症介质的多中心葡萄膜炎试验

• 批准号: 8737638
• 负责人: Robert Nussenblatt
• 金额: $ 6.15万
• 依托单位: NATIONAL EYE INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8737638
• 关键词: Adrenal Cortex Hormones; Blindness; Disease; Fluocinolone Acetonide; Immunosuppressive Agents; Implant; Inflammation; Inflammation Mediators; Intermediate Uveitis; Living Costs; Oral; Outcome; Panuveitis; Patients; Pharmaceutical Preparations; Posterior Uveitis; Quality of life; Randomized; Retinal; Steroids; Systemic Therapy; United States; Uveitis; Vision; Visual Acuity; comparative efficacy; cost effectiveness; design; high risk; standardize guidelines; success; treatment trial

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.

葡萄膜炎是指以眼内炎症为特征的几种眼部疾病，其在美国总体上是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葡萄膜炎的更严重形式，具有最高的视力丧失风险，通常需要长期全身治疗。醋酸氟轻松眼内植入物是一种手术植入的皮质类固醇储库，设计持续约2.5年，以提供长期控制葡萄膜炎。 多中心葡萄膜炎类固醇治疗（MUST）试验的主要目的是比较标准化全身治疗与醋酸氟轻松植入治疗严重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，活动性葡萄膜炎患者将以1：1的分配比例随机接受醋酸氟轻松植入剂治疗或标准化全身治疗（包括口服皮质类固醇和补充免疫抑制药物）。该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，控制葡萄膜炎的成功，视网膜形态学结果，生活质量，成本效益，以及葡萄膜炎和治疗的潜在眼部和全身并发症的发生。