A 24-week, Open-label, Prospective, Single-arm Study Evaluating the Effectiveness and Safety of Lucentis® (Ranibizumab) 0.2mg in Retinopathy of Prematurity (ROP) Participants in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Number of participants with absence of active Retinopathy of Prematurity (ROP) and absence of unfavorable structural outcomes in both eyes during the observational period after starting study treatment.
研究概览
简要总结
This is a 24-week, multicenter, open-label, single-arm, observational, post approval commitment study, which is designed to collect effectiveness, safety and other clinical information of intravitreal ranibizumab 0.2 mg for the treatment of Retinopathy of Prematurity (ROP) participants in a real world clinical setting in mainland China.
详细描述
Eligible participants treated according to local routine clinical practice will be enrolled in the study upon signing an Informed Consent.
Participants will enter the study when they receive their first treatment and are followed up for 24 weeks. During the follow up period, participants could receive post-baseline treatment (i.e., ranibizumab or laser therapy) Patients will be treated according to the approved label and standard of care and as per Investigator judgement.
End of study will be defined as completion of the week 24 visit or premature withdrawal visit
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 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent from parent(s) or legal guardian(s), in compliance with local requirements
- •Male or female preterm infants with a birth weight of less than 1500 g
- •Bilateral ROP with 1 of the following retinal findings in each eye:
- •Zone I, stage 1+, 2+, 3 or 3+ disease, or
- •Zone II, stage 3+ disease, or
排除标准
- •Have a history of hypersensitivity (either the patient or the mother) to ranibizumab or any component of the ranibizumab formulation or to drugs of similar chemical classes
- •Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
- •Have used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever is longer
- •Have received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy)
- •Participants who have contraindications according to locally approved ranibizumab label
结局指标
主要结局
Number of participants with absence of active Retinopathy of Prematurity (ROP) and absence of unfavorable structural outcomes in both eyes during the observational period after starting study treatment.
时间窗: Week 24
To achieve this outcome, participants cannot fulfill any of the following criteria: * Require intervention for ROP in either eye at or before the 24week assessment visit with a treatment modality other than ranibizumab * Have active ROP in either eye at the 24week assessment visit * Have unfavorable structural outcomes in either eye at or before 24-week assessment visit
次要结局
- Incidence of AEs(Up to 24 weeks)
- Assessment of weight(Baseline, Week 12, and Week 24)
- Assessment of head circumference(Baseline, Week 12, and Week 24)
- Full retinal vascularization in 12 clock hours(Week 24)
- Assessment of length(Baseline, Week 12, and Week 24)
- Assessment of lower leg length(Baseline, Week 12, and Week 24)
- Time to intervention with a second modality for ROP or development of unfavorable structural outcome(Up to 24 weeks)
- Proportion of participants with re-treatment of ROP receiving any post-baseline intervention(24 weeks)
- number of ranibizumab administrations needed in the treatment of participants with ROP(24 weeks)