验证基于趋势的终点,用于眼中神经保护试验.
Giovanni Montesano1,2, David F Garway-Heath2, Alessandro Rabiolo3,4
1City, University of London, Optometry and Visual Sciences, London, UK.
Translational vision science & technology
|October 31, 2023
概括
基于趋势的视野进展方法在检测治疗效果方面表现出比基于事件的方法更强大的能力. 这些发现表明基于趋势的方法在评估青光眼治疗方面更有效.
科学领域:
- 眼科医生 眼科 眼科
- 临床试验 临床试验
- 统计分析 统计分析
背景情况:
- 评估视野 (VF) 进展对于评估青光眼治疗疗效至关重要.
- 目前美国食品和药物管理局 (FDA) 接受的方法依赖于基于事件的标准.
- 与基于事件的方法相比,基于趋势的进展检测方法的力量仍然不太了解.
研究的目的:
- 为了比较基于趋势的VF进展终点与FDA接受的基于事件的终点的统计能力.
- 评估基于趋势的方法在检测青光眼的模拟治疗效果方面的效率.
主要方法:
- 分析了3352名患者的VF数据,随访时间中位数为11年.
- 模拟的2年试验系列 (1000次代) 具有神经保护治疗效果.
- 评估了基于趋势的线性混合模型 (LMM) 和时间向进展 (TTP) 方法,与FDA-7和GPA类似的基于事件的标准对比.
主要成果:
- 基于趋势的方法 (LMM和TTP) 比基于事件的方法显示出明显更高的功率.
- 基于事件的方法中没有一种在检测进展方面达到80%的功率.
- 所有评估的方法都保持了5%的错误阳性率.
结论:
- 基于趋势的方法是有效和强大的检测治疗效应,定义的长期,FDA兼容的进展.
- 这些发现支持了基于趋势的分析在眼的临床试验中的有用性.
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