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在糖尿病斑点患者中CT- P42的长期有效性和安全性:52周的随机临床试验结果
David M Brown1, Sebastian Wolf2,3, Milan Veselovsky4
1Retina Consultants of Texas, Retina Consultants of America, Houston, TX, USA.
Ophthalmology and therapy
|August 29, 2025
概括
长期数据显示,生物类似物CT- P42的疗效和安全性与参考药物aflibercept在治疗糖尿病黄斑的疗效和安全性相当. 这些发现支持CT- P42作为患者的可比治疗选择.
科学领域:
- 眼科 眼科
- 内分泌学
- 药理学
背景情况:
- 糖尿病黄斑 (DME) 是糖尿病患者视力丧失的主要原因.
- 虽然Aflibercept是DME的标准治疗方法,但生物类似药可以节省成本.
- 之前的24周数据表明CT- P42在有效性和安全性方面与参考aflibercept可比.
研究的目的:
- 评估CT- P42与DME患者的参考药物相比的长期 (52周) 疗效,安全性和免疫性.
- 通过延长治疗时间来确认CT- P42的治疗等效性.
主要方法:
- 一个为期52周的,随机的,双面罩的,主动控制的国际第三阶段试验.
- 患有DME的成年人通过静脉内注射接受CT- P42或参考aflibercept (2 mg).
- 开始每4周服用5剂,然后改为每8周服用4剂.
主要成果:
- 306名参与者完成了为期52周的研究.
- 平均最好的视力度改善保持在不同组之间 (12. 1个字母用于CT- P42和11. 1个字母用于aflibercept).
- 在CT- P42和参考aflibercept之间,中心子场厚度变化,安全性概况和免疫性是可比的.
结论:
- 通过52周的长期结果证实了CT- P42和参考aflibercept的治疗等价性.
- 在治疗糖尿病黄斑瘤方面,CT- P42的长期疗效,安全性和免疫性相似.
- CT-P42 是一种可行的生物仿制品替代品.
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