Regulatory Post-Marketing Surveillance(PMS) Study for Lucentis®(Ranibizumab) in Patients With Retinopathy of Prematurity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Incidence of adverse events/adverse drug reactions
研究概览
简要总结
This study was an open-labeled, multicenter, single arm, observational post-marketing surveillance study under routine clinical practice with no mandated treatments, visits or assessments.
详细描述
The investigators collected safety information and evaluated effectiveness in patients who were prescribed with Lucentis® (Ranibizumab) injection in Retinopathy of Prematurity indication after receiving informed consent over a period of 4 weeks.
Subjects who received multiple doses, i.e., 2 or more doses, of Lucentis® injection were defined as subjects with long-term use, and the safety and effectiveness information of up to 12 weeks was collected and analyzed separately.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants with retinopathy of prematurity (ROP)
- •Patients (infants) prescribed with Lucentis® injection according to the product approval information in the Republic of Korea
- •In the case that the legal guardian of the patient (infant) provided a written consent to participate in this study
排除标准
- •In the case that the legal guardian of the patient (infant) does not want participation in this study
- •In the case that it falls under any of the contraindications listed in local prescribing information of Lucentis® injection
- •Patients with hypersensitivity to the active substance or to any of the excipients
- •Patients with an active or suspected ocular or periocular infection.
- •Patients with active intraocular inflammation
结局指标
主要结局
Incidence of adverse events/adverse drug reactions
时间窗: Up to 12 weeks
Incidence of adverse events/adverse drug reactions, serious adverse events/adverse drug reactions, unexpected adverse events/adverse drug reactions, suspected unexpected serious adverse reactions/adverse drug reactions were collected
次要结局
- Proportion of treatment success(Up to 12 weeks)