PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Proportion of patients with Adverse Events(AEs) and Adverse Drug Reactions(ADRs)
研究概览
简要总结
This is an open-label, single-arm phase I/II trial to evaluate the safety and efficacy of Rho-associated protein kinase(ROCK) inhibitor Ripasudil eye drops for preterm infants with Retinopathy of Prematurity(ROP).
详细描述
Ripasudil eye drops will be administrated to all enrolled preterm infants with zone I/II stage 1 or greater ROP （except for aggressive posterior ROP, Type1 ROP ）.
The safety and efficacy of ripasudil in treated patients will be assessed in comparison to a historical control.
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
- — 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed by parents or legal guardians of the patient
- •Patients born with less than or equal to 32 weeks of gestational age and/or less than or equal to 1,500 grams of birth weight
- •Patients with the following types of ROP in both eyes
- •Zone I ROP with stage greater than or equal to 1
- •Zone II ROP with stage greater than or equal to 1
排除标准
- •Patients with aggressive posterior ROP in one or both eyes
- •Patients with type 1 ROP in one or both eyes
- •Patients with a confirmed or suspected chromosomal abnormality or genetic disorder
- •History of hypersensitivity to ripasudil (including drugs with similar chemical structure) in patients or their mothers
- •Patients or their mothers have participated in another intervention study and have used the study drug of another intervention study within 30 days prior to enrollment in this study or within 5 times the half-life of the study drug
- •Patients with an ocular structural abnormality that can affect the evaluation of this clinical study by investigators
- •Patients with a clinically significant neurological disease (e.g., intraventricular hemorrhage grade 3 or higher, severe hydrocephalus with significantly increased intracranial pressure)
- •Patients with inadequate blood access
- •Patients with complications, allergies, or worsening systemic conditions that make it difficult to conduct this trial
- •Patients judged unsuitable by investigators
研究组 & 干预措施
Ripasudil eye drops
Ripasudil eye drops
干预措施: Ripasudil ophthalmic solution 0.4% (Drug)
结局指标
主要结局
Proportion of patients with Adverse Events(AEs) and Adverse Drug Reactions(ADRs)
时间窗: throughout the study duration(up to week16)
Safety Assessment
次要结局
- Concentration of ripasudil and its metabolite M1(throughout the study duration(up to week12))
- Proportion of patients with ROP remission in both eyes(week12 of treatment)
- Proportion of patients whose ROP worsens to Type1 ROP in one or both eyes(week12 of treatment)
研究者
Mitsuru Arima
Center for Clinical and Translational Research
Kyushu University