ASRS 2020:AAV-RPGR基因疗法治疗X-性连锁遗传性视网膜劈裂症,患者视力显着改善

2020-07-18 MedSci原创 MedSci原创

治疗六个月的数据显示,低剂量和中剂量均耐受良好,并且患者视力明显改善。

在2020年美国视网膜专家协会(ASRS)线上会议上,强生公司宣布了其基因疗法AAV-RPGR治疗X-性连锁遗传性视网膜劈裂症(XLRS)的1/2期临床试验结果(NCT03252847)。

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AAV-RPGR是腺相关病毒包载的视网膜色素变性GTP酶调节剂(RPGR),治疗六个月的数据显示,低剂量和中剂量均耐受良好,并且患者视力明显改善。

在XLRP患者中,负责将光转换为信号并发送到大脑的眼部感光细胞功能缺陷,导致视网膜变性和成年后失明,目前尚无针对该疾病获批的治疗方法。

治疗六个月后,低剂量(n = 3)和中剂量(n = 4)组患者显示出治疗后视网膜敏感性较基线明显改善。使用两种视野检查方法(静态视野检查和显微视野检查)和三种分析度量(平均视网膜敏感性、30°视线中央容积测量[V30]和逐点比较)进行评估时,这些改善是显而易见的。

最常见的不良事件与外科手术有关,短暂且无需干预即可解决。在高剂量组(n = 3)中,三名成年患者中有两名患者明显发炎,视觉功能指标未得到改善。

伦敦大学学院眼科教授Michel Michaelides表示:“这是一种迫切需要新型疗法的疾病,以避免患者成年后失眠。1/2期临床试验中提供了重要的安全性和有效性信息,希望将这些发现将进一步应用于下一阶段的研究。”

原始出处:

https://www.firstwordpharma.com/node/1741544?tsid=4

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    2021-01-30 nian.wang1982
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    2020-07-20 老婆子

    看不懂耶

    0

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    2020-07-20 zutt
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    2020-07-20 xuqianhua