NCT07623668招募中3 期
A Randomized, Double-masked, Placebo-controlled Study Assessing the Efficacy and Safety of Privosegtor (OCS-05) in Patients With Optic Neuritis (ON)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Oculis
- 入组人数
- 210
- 试验地点
- 4
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and efficacy of privosegtor, a neuroprotective candidate, in patients diagnosed with optic neuritis (ON).
Researchers will compare privosegtor and the standard of care (methylprednisolone) to a placebo and standard of care (methylprednisolone).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women (aged 18 to 50 years) with the first episode of ON in the study eye, associated with unilateral visual loss.
- •Onset of visual loss symptoms in the previous 12 days before first administration of study treatment.
排除标准
- •- Have a history or presence of any disorder or condition that may, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety
研究组 & 干预措施
Privosegtor
Experimental
干预措施: Privosegtor (Drug)
Placebo
Placebo Comparator
干预措施: Methylprednisolone (Drug)
Privosegtor
Experimental
干预措施: Methylprednisolone (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
未指定
次要结局
- Proportion of participants achieving at least 30-letter gain from baseline in low contrast visual acuity (LCVA).(3 months)
- Mean change from baseline in low contrast visual acuity (LCVA).(3 months)
研究者
研究点 (4)
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