NCT04515524进行中（未招募）不适用
An Extension Study to Evaluate the Long-Term Outcomes of Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 30
- 主要终点
- Proportion of Patients with Serious Adverse Events
研究概览
简要总结
Primary objectives of the study are:
- To evaluate binocular visual acuity at the end of this study in patients included from the VGFTe-ROP-1920 study, for treatment of Retinopathy of Prematurity (ROP).
- To evaluate long-term safety outcomes in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
Secondary objectives of the study are:
- To describe visual function in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
- To describe overall development in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
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
- 11 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient was treated in study VGFTe-ROP-1920
- •Age <13 months of chronological age
- •Signed informed consent from parent(s)/legal guardian(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
排除标准
- •Patient has a condition preventing participation in the study, or performance of study procedures
- •NOTE: Other Inclusion/Exclusion criteria may apply
结局指标
主要结局
Proportion of Patients with Serious Adverse Events
时间窗: Up to 5 years of chronological age
Binocular best-corrected visual acuity (BCVA)
时间窗: 5 years of chronological age
Proportion of Patients with Adverse Events
时间窗: Up to 5 years of chronological age
次要结局
- BCVA in each eye(3 year of chronological age, 5 years of chronological age)
- Neurodevelopmental outcomes using BSID-III(2 years of chronological age)
- Neurodevelopmental outcomes using WPPSI-IV(5 years of chronological age)
- Proportion of patients with recurrence of ROP(3 years of chronological age, 5 years of chronological age)
- Proportion of patients requiring treatment for ROP(Through 5 years of chronological age)
- Proportion of patients developing unfavorable ocular structural outcome(3 years of chronological age, 5 years of chronological age)
- Refractive spherical equivalent in each eye(3 years of chronological age, 5 years of chronological age)
- Neurodevelopmental outcomes using VABS-II(2 years of chronological age, 5 years of chronological age)
研究者
研究点 (30)
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