Multicenter Uveitis Steroid Treatment (MUST) Trial

多中心葡萄膜炎类固醇治疗 (MUST) 试验

• 批准号: 8655154
• 负责人: Douglas A Jabs
• 金额: $ 33.51万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 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 2017-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8655154
• 关键词: Address; Adrenal Cortex Hormones; Adverse effects; Autoimmune Process; Blindness; Cataract; Choroidal Neovascularization; Clinical Management; Clinical Research; Clinical Treatment; Clinical Trials; Clinical Trials Network; Data; Disease; Effectiveness; Epidemiologic Studies; Epiretinal Membrane; Fluocinolone Acetonide; Future; Glaucoma; Goals; Group Structure; Humira; Immunosuppression; Immunosuppressive Agents; Implant; Inflammation; Instruction; Laboratories; Local Therapy; Lucentis; Monoclonal Antibodies; Oral; Outcomes Research; Patient Agents; Patients; Pharmaceutical Preparations; Pharmacotherapy; Phase; Physiologic Intraocular Pressure; Pilot Projects; Principal Investigator; Process; Randomized Controlled Clinical Trials; Refractory; Relative (related person); Research; Research Technics; Retinal Neovascularization; Rheumatoid Arthritis; Safety; San Francisco; Series; Steroids; Structure; Systemic Therapy; Treatment Efficacy; Triamcinolone Acetonide; Tumor Necrosis Factor-alpha; United States Food and Drug Administration; Uveitis; Vascular Endothelial Growth Factors; Vision; Work; adalimumab; cohort; comparative trial; compare effectiveness; effective therapy; evidence base; follow-up; high risk; human monoclonal antibodies; macular edema; primary outcome; ranibizumab; research study; standard care; treatment trial; trial comparing

The goal ofthis proposal is to develop a clinical trials network capable of engaging in several clinical trials of the treatments of uveitis and its complications. The MUST Research Group (RG) structure already is in place, and processes have been developed for review, approval, and prioritization of clinical trials. Four clinical research studies are proposed as the initial activities ofthe proposed network, which represent the specific aims ofthe proposal. These are: 1) To continue the current MUST Trial follow-up past the original two-year determination ofthe primary outcome for an additional 6 years. This long-term follow-up will enable the MUST RG to evaluate the long-term consequences ofthe two treatment paradigms: regional corticosteroid treatment v. systemic therapy with corticosteroids and immunosuppression; 2) To compare the relative effectiveness of adalimumab (Humira(R), Abbott Laboratories, Abbott Park, IL), a fully human monoclonal antibody to TNF-a v. conventional immunosuppression for patients with severe uveitis requiring immunosuppressive drug therapy. Adalimumab already is approved by the US Food and Drug Administration (FDA) for the treatment of several autoimmune or autoinflammatory diseases, such as rheumatoid arthritis, and preliminary data suggest that it is effective as a corticosteroid-sparing agent in patients with uveitis; 3) To compare periocular v. intravitreal corticosteroids for the treatment of macular edema in patients with uveitis. Both periocular and intravitreal corticosteroids appear to be effective for the treatment of macular edema in patients with uveitis, but no comparative trials have been performed. Many clinicians believe that intravitreal corticosteroids are more effective than periocular corticosteroids for this indication, but that they also have higher rates of side effects; and 4) To compare intravitreal ranibizumab (Lucentis(R), Genentech Inc., San Francisco, CA), a monoclonal antibody to vascular endothelial growth factor, to intravitreal corticosteroids for the treatment of refractory macular edema in patients with uveitis. A pilot study suggested that ranibizumab was effective in the treatment of uveitic macular edema and that potentially it may have less ocular side effects than corticosteroids. However, the relative efficacy ofthe two treatments is unknown. RELEVANCE (See instructions): Non-infectious uveitis is associated with high rates of visual loss and usually requires long-term therapy, often with oral corticosteroids, supplemented, when indicated, by immunosuppressive (corticosteroid- sparing) drugs. Visual loss often is caused by structural complications, e.g., macular edema. We propose to carry out a series of clinical studies to provide an evidence base for the management ofthese conditions.

本提案的目标是建立一个能够参与多种临床试验的临床试验网络