Treatment of Optic Neuritis With Erythropoietin: a Randomised, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 11
- 主要终点
- Global retinal nerve fibre layer thickness (RNFLT-G)
研究概览
简要总结
This clinical trial aims at preventing visual dysfunction and optic nerve degeneration associated with autoimmune optic neuritis by systemic i.v. administration of 33.000 IU erythropoietin over 3 days. The primary objective is to determine the efficacy of erythropoietin compared to placebo given as add-on to methylprednisolone as assessed by measurements of retinal nerve fibre layer thickness and low contrast visual acuity 6 months after acute optic neuritis.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Erythropoietin alfa
Recombinant human EPO (Epoetin alfa HEXAL®) will be given as an i.v. bolus injection on days 1, 2 and 3. The dosage per day will be 33.000 IU in accordance with previous trials.
干预措施: Erythropoietin alfa (Drug)
Placebo
As matched placebo for this study, sterile normal saline (0.9% sodium chloride for i.v. administration) will be used. It will be given as a bolus injection in the same manner as EPO.
干预措施: Placebo (Drug)
结局指标
主要结局
Global retinal nerve fibre layer thickness (RNFLT-G)
时间窗: 6 months
Determination of the efficacy of erythropoietin compared to placebo given as add-on to methylprednisolone (standard of care) as assessed by measurement of global retinal nerve fibre layer thickness (RNFLT-G) in the affected eye 6 months after randomisation.
Low contrast visual acuity (LCVA)
时间窗: 6 months
Determination of the efficacy of erythropoietin compared to placebo given as add-on to methylprednisolone (standard of care) as assessed by measurement of low contrast visual acuity (LCVA) in the affected eye 6 months after randomisation.
次要结局
- Absolute values of the global retinal nerve fibre layer thickness(6 months)
- Retinal nerve fibre layer thickness in the papillomacular bundle(6 months)
- Retinal nerve fibre layer thickness in the temporal quadrant(6 months)
- Total macular volume(6 months)
- Visual acuity(6 months)
- Contrast sensitivity(6 months)
- Mean visual field defect(6 months)
- Latency [ms] and amplitude [µV] of visual evoked potentials (VEP)(6 months)
- Expanded Disability Status Scale (EDSS) score(6 months)
- Quality of life(6 months)
- Safety(Screening until end of study)
研究者
Prof. Dr. Wolf Lagrèze
Prof. Dr. med.
University Eye Hospital, Freiburg