尼古丁胺和Pyruvate在开放角度玻璃眼 (NIC-OAG):一个随机控制的神经保护试验 - 设计和方法
Aakriti Garg Shukla1, Emmanouil Tsamis1, Carlos Gustavo De Moraes1
1Department of Ophthalmology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA; Bernard and Shirlee Glaucoma Research Laboratory, Columbia University Irving Medical Center, New York, New York, USA.
Ophthalmology. Glaucoma
|December 29, 2025
概括
这项试验调查了尼古丁胺和酸盐补充剂是否可以防止在开角玻璃眼 (OAG) 中的视力损失. 研究人员正在评估接受标准治疗的患者的功能和结构变化.
科学领域:
- 眼科医生 眼科 眼科
- 神经保护是一种神经保护.
- 在眼部疾病中的代谢途径.
背景情况:
- 开角光眼 (OAG) 是不可逆转失明的主要原因.
- 目前的治疗主要集中在降低眼内压力,但神经保护仍然是一个关键的未满足需求.
- 尼古丁胺和酸盐的食补充剂显示了对眼睛组织代谢支持的潜力.
研究的目的:
- 为了确定尼古丁胺和酸盐的食补充剂是否能在接受治疗的OAG.患者中提供神经保护.
- 评估这种新型治疗方法的疗效和安全性.
主要方法:
- 一个前性的,两个地点的,第三阶段随机临床试验 (NIC-OAG试验).
- 持续时间21个月,安慰剂控制,双面罩设计.
- 参与者接受标准的OAG治疗加上每天3g的尼古丁胺和1g/day的酸盐或安慰剂.
主要成果:
- 主要结果是视野和光学连贯性断层扫描变化的复合.
- 二级结局包括耐受性,安全性和响应性患者子组的识别.
- 从血液样本中分析代谢学,转录学和蛋白学.
结论:
- 该NIC-OAG试验旨在获得关于尼古丁胺和酸盐在青光眼中的神经保护作用的重要数据.
- 这些发现可能有助于我们更好地理解对格洛科马神经保护研究的最佳临床试验设计.
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