阿弗利塞普特2毫克用于神经血管与年龄相关的黄斑退化:在3年后XTEND
Jean-François Korobelnik1,2, Varun Chaudhary3, Paul Mitchell4
1CHU Bordeaux, Service d'Ophtalmologie, Bordeaux, France, jean-francois.korobelnik@chu-bordeaux.fr.
概括
长期数据显示,在患有新血管与年龄相关的黄斑变性 (nAMD) 的患者中,静脉内阿弗利塞普 (IVT-AFL) 2毫克持续改善了视力. 这项现实研究证实了IVT-AFL在nAMD治疗中的耐用性.
科学领域:
- 眼科医生 眼科 眼科
- 视网膜疾病 视网膜疾病
- 药理学 药理学是指药理学的学科.
背景情况:
- 神经血管与年龄相关的黄斑变性 (nAMD) 需要长期的治疗策略.
- 对于nAMD的2毫克静脉内阿弗利塞普特 (IVT-AFL) 长期有效性的现实数据有限.
- 这项研究解决了对IVT-AFL 2 mg在nAMD中的全球,现实世界的证据的需求.
研究的目的:
- 为了评估IVT-AFL 2 mg的长期 (36个月) 现实世界的有效性和安全性,在以前没有接受过治疗的nAMD患者中.
- 为了评估视觉敏度和中央子场厚度变化超过36个月.
- 为了确定与长期IVT-AFL 2 mg治疗相关的任何新的安全问题.
主要方法:
- XTEND研究:一个多中心,观察性,前性研究.
- 在2019年5月至2020年5月期间,1,483名尚未接受过治疗的nAMD患者被招募.
- 患者接受了IVT-AFL 2 mg,固定或治疗和扩展 (T&E) 剂量为36个月.
主要成果:
- 通过36个月,平均视力敏度得到改善,中央子场厚度下降.
- 从基线看,最佳校正视敏度的平均变化为+0.9 (95% CI: -0.2,1.9) 在36个月.
- 与基线相比,中部子场厚度的平均变化为-36个月后-110μm (95% CI:-118,-103);没有发现新的安全问题.
结论:
- 在36个月的时间里,IVT-AFL 2mg在改善视力和减少视网膜厚度方面表现出持续的有效性.
- 长期的视力持久性是可以实现的IVT-AFL 2毫克在现实世界实践中治疗-naive nAMD.
- 该研究支持继续使用IVT-AFL 2 mg用于在常规临床环境中管理nAMD.
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