Phase 2 Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangiectasia Type 2 (MacTel) (14-EI-0078, 17-EI-0136)

睫状神经营养因子 (CNTF) 治疗 2 型黄斑毛细血管扩张症 (MacTel) 的 2 期临床试验 (14-EI-0078、17-EI-0136)

• 批准号: 10020023
• 负责人: Henry Wiley
• 金额: $ 3.3万
• 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/10020023
• 关键词: Affect; Area; Blindness; Ciliary Neurotrophic Factor; Degenerative Disorder; Devices; Disease; Enrollment; Eye; Goals; Implant; Measures; Nerve Degeneration; Participant; Phase; Phase II Clinical Trials; Phase III Clinical Trials; Photoreceptors; Placebos; Protocols documentation; Publications; Retina; Retinal; Safety; Site; Telangiectasis; Testing; follow-up; macula; primary endpoint

We initiated this project at the NEI in fiscal year 2014 as a site in the phase 2 clinical trial (14-EI-0078) testing CNTF for macular telangiectasia (MacTel). We met the accrual goal at the NEI site and study analysis has been completed, with publication of the primary results. The trial met its primary endpoint, with eyes receiving sham treatment showing 31% greater progression of neurodegeneration than the CNTF-treated eyes using an en face OCT measure of change in area of outer retinal disruption, with difference in mean area of photoreceptor loss of 0.05 0.03 mm2 (p = 0.04) at 24 months. The phase 2 protocol has been terminated following completion. Participants in the phase 2 trial were enrolled in an extension study (17-EI-0136) to study effects of the CNTF implant at years 3, 4, 5, and 6, and follow up continues for site participants in this protocol. In 2018, we were activated as a site in the phase 3 clinical trial (18-EI-0055) testing CNTF (NT-501, Renexus) for Mactel (listed as a separate project).

我们在2014财政年度的NEI启动了该项目，作为第二阶段临床试验（14-EI-0078）测试CNTF的地位毛毛虫（Mactel）（MACTEL）。 我们在NEI网站上达到了应计目标，并且已经完成了研究分析，并发表了主要结果。该试验符合其主要终点，而眼睛接受假治疗，显示出与CNTF处理的眼睛相比，使用了1 OCT量度，使用了视网膜外部破坏面积的变化，而光感受器损失的平均面积为0.05 0.03 mm2（p = 0.04）。 完成后，第二阶段协议已终止。 第2阶段试验的参与者参加了一项扩展研究（17-EI-0136），以研究CNTF植入物在第3、4、5和6年的效果，并继续进行该协议中的现场参与者的跟进。 2018年，我们在Mactel（列为一个单独的项目）中，在第三阶段临床试验（18-EI-0055）测试CNTF（NT-501，Renexus）测试CNTF（NT-501，Renexus）中被激活。