人工智能指导的神经保护试验的终点选择
medRxiv : the preprint server for health sciences
|September 5, 2025
概括
一个新的AI模型识别了高风险的视野位置, 这种方法显著提高了检测有意义的视野变化的试验效率和灵敏度.
科学领域:
- 眼科 眼科
- 人工智能
- 医学成像
背景情况:
- 标准自动周边测量 (SAP) 对于监测青光眼的进展至关重要.
- 美国食品和药物管理局接受SAP作为试验终点需要严格的进展标准.
- 在临床试验中确定高风险的视野位置仍然是一个挑战.
研究的目的:
- 开发基于注意力的图形神经网络 (GNN),以预测视野最有可能恶化的点 (High-5).
- 验证GNN模型识别进展和提高临床试验效率的能力.
主要方法:
- 使用基准SAP数据开发了基于注意力的GNN模型.
- 在三个大数据集中训练和验证模型:BPOR,DGR和UWHVF.
- 将高-5位置与平均偏差 (MD) 和低-5点的预测性能进行比较.
主要成果:
- 与Low-5和MD相比,高5分的患者在所有队列中表现出明显更快的恶化率.
- 在GNN模型中,有较高的分辨率 (AUC为0.883-0.937).
- 在几乎所有病例中发现高5的进展,导致所需试验大小减少了42%.
结论:
- 基于GNN的框架可以通过数据来识别高风险的SAP位置.
- 这种方法符合监管对进展的定义,并提高了试验的敏感性.
- 高5方法大大提高了青光眼临床试验的效率和功率.
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