2024-513231-24-00招募中3 期
An Extension Study to Evaluate the Long-Term Outcomes of Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study
Regeneron Pharmaceuticals Inc.3 个研究点 分布在 2 个国家目标入组 7 人开始时间: 2024年10月4日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- Binocular best-corrected visual acuity (BCVA)
研究概览
简要总结
The 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 ROP. • To evaluate long-term safety outcomes in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
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
Binocular best-corrected visual acuity (BCVA)
Binocular best-corrected visual acuity (BCVA)
Proportion of Patients with Adverse Events
Proportion of Patients with Adverse Events
Proportion of Patients with Serious Adverse Events
Proportion of Patients with Serious Adverse Events
次要结局
- Neurodevelopmental outcomes using VABS-II
- BCVA in each eye
- Neurodevelopmental outcomes using WPPSI-IV
- Refractive spherical equivalent in each eye
- Proportion of patients with recurrence of ROP
- Proportion of patients requiring treatment for ROP
- Proportion of patients developing unfavorable ocular structural outcome
- Neurodevelopmental outcomes using BSID-III
研究者
Clinical Trial Information
Scientific
Regeneron Pharmaceuticals Inc.
研究点 (3)
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