Humanized Anti-Tac in the treatment of uveitis

人源化 Anti-Tac 治疗葡萄膜炎

• 批准号: 6227959
• 负责人: ROBERT B. NUSSENBLATT
• 金额: --
• 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/6227959
• 关键词: antireceptor antibody; clinical research; cytokine receptors; eye disorder chemotherapy; human subject; human therapy evaluation; immunosuppressive; immunotherapy; interleukin 2; monoclonal antibody; uveitis

The goal of this study is to evaluate the safety and potential therapeutic activity of humanized anti-IL-2 receptor monoclonal antibody (Daclizumab) therapy in the treatment of patients with severe, sight-threatening, intermediate and posterior non-infectious uveitis.This is a non-randomized, open-label, pilot study. Patients with chronic, non-infectious bilateral, sight-threatening uveitis who were treated with a minimum of 20 mg of prednisone, cyclosporine, anti- metabolites, or any combination of these agents were eligible. Patients were weaned off these immunosuppressive agents according to a standardized schedule, while ultimately receiving Daclizumab infusions every 4 weeks.Anti-Interleukin 2 receptor antibody therapy, given intravenously with intervals of up to four weeks in lieu of standard immunosuppressive therapy, appeared to prevent the expression of severe sight-threatening intraocular inflammatory disease in nine of ten patients treated for a minimum of seven months, based on the primary end point of a loss of vision of 10 letters or more from baseline in either eye. All patients were able to tolerate the study medications without the need for dose reduction. - uveitis, Interleukin-2, anti-Tac antibody, immunosuppression, - Human Subjects

这项研究的目的是评估人源化抗IL-2受体单克隆抗体（Daclizumab）治疗的安全性和潜在治疗活性，以治疗严重，视力威胁性，中等和非感染性的葡萄酒患者。患有慢性，非感染双侧，视力威胁葡萄膜炎的患者接受治疗至少20 mg泼尼松，环孢菌素，抗代谢产物或任何组合这些药物的患者。根据标准化时间表，将患者断奶这些免疫抑制剂，同时每4周接受Daclizumab注入。几个月，基于双眼基线的10个字母或更多视力丧失的主要终点。所有患者都能忍受研究药物而无需降低剂量。 - 葡萄膜炎，白介素2，抗TAC抗体，免疫抑制，人类受试者