在临床试验中使用抗VEGF剂的眼部并发症的国际分类系统
Marko M Popovic1, Michael Balas1, SriniVas R Sadda2
1Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.
Ophthalmology
|June 15, 2024
概括
使用德尔菲共识过程开发了一种针对抗血管内皮生长因子 (anti-VEGF) 眼部并发症的新标准化分类系统. 该系统旨在改善对抗VEGF疗法的临床试验中的安全报告的一致性.
科学领域:
- 眼科医生 眼科 眼科
- 临床试验 临床试验
- 医疗信息学 医疗信息学
背景情况:
- 不一致的 intravitreal anti-VEGF疗法并发症报告阻碍了安全性评估.
- 为了在不同研究中准确比较抗VEGF安全性,需要进行标准化分类.
研究的目的:
- 开发一种标准化的分类系统,用于与内抗VEGF药物相关的眼部并发症.
- 提高临床试验中的安全数据的一致性和可比性.
主要方法:
- 对涉及抗VEGF治疗的随机对照试验 (RCT) 的系统文献综述.
- 德尔菲共识过程涉及25名国际视网膜专家.
- 代调查以完善并发症定义和规范.
主要成果:
- 最初从145个RCT中确定了130种并发症的综合清单.
- 德尔菲过程最终分类了67种眼部并发症和47种特征.
- 参与者达成共识,包括52%的确诊并发症和63%的拟议特异剂.
结论:
- 成功建立了针对内抗VEGF眼部并发症的标准化分类系统.
- 采用这种系统可以提高临床试验中不良事件报告的一致性和质量.
- 这种标准化将促进对抗VEGF疗法的更准确的风险效益分析.
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