NCT04015180已完成3 期
An Extension Study to Evaluate the Long-term Outcomes of Subjects Who Received Treatment for Retinopathy of Prematurity in Study 20090
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 100
- 试验地点
- 55
- 主要终点
- Proportion of subjects with systemic AEs and SAEs
研究概览
简要总结
This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 13 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject was treated in Study 20090
- •Age less than 13 months of chronological age
- •Signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
排除标准
- •- Subject has a condition preventing participation in the study, or performance of study procedures.
研究组 & 干预措施
Aflibercept arm
Experimental
No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.
干预措施: Eylea (Aflibercept, BAY86-5321) (Drug)
Laser photocoagulation arm
Active Comparator
No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.
干预措施: Laser photocoagulation (Procedure)
结局指标
主要结局
Proportion of subjects with systemic AEs and SAEs
时间窗: Up to 5 years of age.
Binocular best-corrected visual acuity in Snellen equivalent
时间窗: At 5 years of age.
Proportion of subjects with ocular AEs and SAEs
时间窗: Up to 5 years of age.
AE: adverse event SAE: serious adverse event
次要结局
- Proportion of subjects with absence of active ROP and unfavorable structural outcomes(At 1 year of age.)
- Refractive spherical equivalent in each eye(At 3 and 5 years of age)
- Proportion of subjects requiring ophthalmological treatment(Up to 5 years of age.)
- Neurodevelopmental outcomes using VABS-II(At 2 and 5 years of age)
- Best-corrected visual acuity in each eye(At 3 and 5 years of age.)
- Neurodevelopmental outcomes using BSID-III(At 2 years of age)
- Proportion of subjects developing unfavorable ocular structural outcome(At 1,3 and 5 years of age.)
- Neurodevelopmental outcomes using WPPSI-IV(At 5 years of age)
- Proportion of subjects with recurrence of ROP(At 3 and 5 years of age.)
- Proportion of subjects requiring treatment for ROP(Up to 5 years of age.)
研究者
研究点 (55)
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