Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change from Baseline Visual Capacity
研究概览
简要总结
The goal of this double-blind prospective randomized clinical trial is to determine if the effect of intravenous erythropoietin is superior to the effect of intravenous methylprednisolone in cases of toxic optic neuropathy 4 weeks after therapeutic intervention.
The main question it aims to answer:
• Is there a difference in the visual recovery of toxic optic neuropathies treated with intravenous methylprednisolone in comparison with those treated with intravenous erythropoietin?
详细描述
A double-blind prospective randomized clinical trial of treatment for toxic optic neuropathies comparing visual outcome of patients treated by standard treatment (intravenous methylprednisolone) vs intravenous erythropoietin.
Enrollment: 18. Randomized groups (2)
- Standard treatment (intravenous methylprednisolone)
- Intravenous erythropoietin
Masking: Double (participant and outcomes assessor) Participants won't be aware to which group they were assigned. Investigator in charge of assessing outcomes and analyzing data won't be aware to which group participants were assigned
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants won't be aware to which group they were assigned. Investigator in charge of assessing outcomes and analyzing data won't be aware to which group participants were assigned.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genres.
- •Age between 18 and 75 years.
- •Clinical diagnosis of toxic optic neuropathy (afferent pupillary defect, acquired dyschromatopsia, visual loss and bilateral prechiasmatic field defect).
- •Exposure with a temporal relationship of less than two weeks to a known toxicant for the function of the optic nerve.
- •Up to 21 days from symptom onset.
- •Informed consent signature.
排除标准
- •History of previous optic neuropathy.
- •History of additional ophthalmological or neurological pathology that has caused permanent visual loss.
- •History of previous treatment with intravenous methylprednisolone or some other experimental treatment since the onset of symptoms.
- •Poorly controlled diabetes mellitus.
- •Poorly controlled systemic arterial hypertension.
- •Hemoglobin >16 mg/dL
- •Patients with a history of thromboembolic event.
- •Patients with a history of coronary heart disease, myocardial infarction or cerebral vascular event.
- •Pregnancy or lactation.
研究组 & 干预措施
Experimental group
The patients will receive intravenous erythropoietin - 10,000 IU every 24 hours for 5 days.
干预措施: Recombinant human erythropoietin 4,000 UI and 2,000 UI (Drug)
Control group
The patients will receive intravenous methylprednisolone - 1 g every 24 hours for 5 days.
干预措施: Methylprednisolone succinate 500 mg (Drug)
结局指标
主要结局
Change from Baseline Visual Capacity
时间窗: Initial visit, 2-week visit, 1-month visit, 3-month visit
Best corrected visual acuity
次要结局
- Change from Baseline Color vision(Initial visit, 2-week visit, 1-month visit, 3-month visit)
- Change from Baseline Visual field defect(Initial visit, 2-week visit, 1-month visit, 3-month visit)
- Change from Baseline Oct pRNFL (microns)(Initial visit, 3-month visit)