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临床试验/NCT05540262
NCT05540262招募中不适用

Edaravone in the Treatment of Optic Neuritis

First Affiliated Hospital of Guangxi Medical University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年1月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Best-corrected visual acuity

研究概览

简要总结

Edaravone has demonstrated a beneficial effect in promoting remyelination and protecting axons in animals with NMOSD. The researchers posit that edaravone may enhance visual outcomes in patients with aquaporin-4 antibody-positive optic neuritis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chinese patients aged ≥18 with anti-aquaporin-4 antibody-positive optic neuritis
  • Patients with a first episode of optic neuritis in either eye
  • First symptoms of optic neuritis ≤30 days prior to the first administration of edaravone

排除标准

  • Myopia over 6 diopters
  • Refractive media opacity affecting assessment of retinal layers and/or visual acuity

研究组 & 干预措施

Edaravone

Experimental

干预措施: Edaravone (Drug)

结局指标

主要结局

Best-corrected visual acuity

时间窗: 18 months

Best-corrected visual acuity will be measured by "Illiterate E"chart.

次要结局

  • Ganglion cell-inner plexiform layer(18 months)
  • Peripapillary retinal nerve fiber layer(18 months)

研究者

发起方
First Affiliated Hospital of Guangxi Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yi Du

Dr.

First Affiliated Hospital of Guangxi Medical University

研究点 (1)

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