Traumatic Optic Neuropathy Treatment Trial 2; Efficacy of Different Doses of Erythropoietin. A Multicenter, Double Blind RCT
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 3
- 主要终点
- Change in Mean LogMAR Best corrected visual acuity (BCVA) from 20/20 to no light perception (NLP) as assessed by Snellen visual acuity chart and analyzed based on mean LogMAR change.
研究概览
简要总结
After introducing intravenous erythropoietin (EPO) as an option for treatment of patients with indirect traumatic optic neuropathy in 2011 and publishing non inferiority trial in Oct.2017), TONTT2 is aiming to find out the best dose and timing of EPO administration in this group of patients.
详细描述
Patients with TON will be visited. After being eligible to enter the study and obtaining informed consent, they will be randomly assigned into 3 groups of different total dose of intravenous administration of EPO to which patients and outcome assessors will be masked. They will be assessed at different follow up time periods with the last follow up of at least 3 months.
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 are unaware of the dose of EPO. Outcome assessors are masked to the dose of EPO
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having indirect traumatic optic neuropathy(with normal eye and fundus exam)
- •Trauma to treatment interval of 3 weeks and less
- •Age of 7 years and more
排除标准
- •Direct optic neuropathy,
- •Any retinopathy
- •Globe laceration
- •Age under 7
- •Hypertension,
- •Polycythemia,
- •Creatinin more than 3 mg/dl,
- •Sensitivity to EPO
- •Patients who have received any other form of treatment for their traumatic optic neuropathy
研究组 & 干预措施
Group 1
Intervention is Intra-Venous injection of Eprex or EPO [recombinant human erythropoietin, Pooyesh Darou Biopharmaceuticals CO., Tehran, Iran, 4000 unit/ml solution in prefilled syringe], 300 units/kg/day for three consecutive days (total:900/kg in 3 days)
干预措施: Recombinant human erythropoietin (Drug)
Group 2
Intervention is Intra-Venous injection of Eprex or EPO [recombinant human erythropoietin, Pooyesh Darou Biopharmaceuticals CO., Tehran, Iran, 4000 unit/ml solution in prefilled syringe], 600 units/kg/day for three consecutive days (total:1800/kg in 3 days)
干预措施: Recombinant human erythropoietin (Drug)
Group 3
Intervention is Intra-Venous injection of Eprex or EPO [recombinant human erythropoietin, Pooyesh Darou Biopharmaceuticals CO., Tehran, Iran, 4000 unit/ml solution in prefilled syringe], 600 units/kg/day for three consecutive days then repetition of the same treatment in month 1 (Total: 3600/kg in 2 set of 3-day treatment, 1 month apart)
干预措施: Recombinant human erythropoietin (Drug)
结局指标
主要结局
Change in Mean LogMAR Best corrected visual acuity (BCVA) from 20/20 to no light perception (NLP) as assessed by Snellen visual acuity chart and analyzed based on mean LogMAR change.
时间窗: Before treatment and on day 1,2,3, 7, 30, and 90 days after the treatment and through study completion, an average of 24 months
Best corrected Visual acuity is measured (Snellen eye chart) and recorded as 20/20-20/25, 20/30, 20/40, 20, 50, 20/70, 20/100, 20/200 and then counting finger (CF), hand motion (HM), light perception (LP), and no light perception (NLP)
次要结局
- Change in Mean Log Unit of Relative afferent pupillary defect (RAPD) from 0.3 to 1.8 log unit as assessed by Neutral density filter(Before treatment and on day 1,2,3, 7, 30, and 90 days after the treatment and through study completion, an average of 24 months)
- Number of patients with treatment related adverse effects as assessed by history taking (change in mood, vertigo, faint), examination (blood pressure) and blood tests (CBC, BUN, Cr., K, Na, PT, PTT, INR, Ca., Ph)(before treatment and on day 1, 2 and 3 after treatment.)
- Change in Mean number of visible color plates in Color vision test book. It is from 14/14 to 0/14 as assessed by Ishihara 14-plate color test book(Before treatment and on day 1,2,3, 7, 30, and 90 days after the treatment and through study completion, an average of 24 months)