2023-504207-89-00招募中3 期
(20275) An extension study to evaluate the long-term outcomes of subjects who received treatment for retinopathy of prematurity in Study 20090
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Bayer AG
- 入组人数
- 39
- 试验地点
- 23
- 主要终点
- Binocular best-corrected visual acuity in Snellen equivalent score at 5 years of age.
研究概览
简要总结
To evaluate long-term safety outcomes and visual function of subjects included in Study 20090 for treatment for retinopathy of prematurity (ROP)
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall study
- 盲法
- None
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
- •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 the protocol
排除标准
- •Subject has a medical condition preventing participation in the study, or performance of study procedures
结局指标
主要结局
Binocular best-corrected visual acuity in Snellen equivalent score at 5 years of age.
Binocular best-corrected visual acuity in Snellen equivalent score at 5 years of age.
次要结局
- Proportion of subjects with ocular adverse events (AEs) and serious AEs (SAEs) through 5 years of age
- Proportion of subjects with systemic AEs and SAEs through 5 years of age
- Proportion of subjects developing unfavorable ocular structural outcome (retinal detachment, macular dragging, macular fold, retrolental opacity) at 1, 3, and 5 years of age
- Proportion of subjects with absence of active ROP and unfavorable structural outcomes at 1 year of age
- Best-corrected visual acuity in each eye at 3 and 5 years of age
- Refractive spherical equivalent in each eye at 3 and 5 years of age
- Proportion of subjects requiring treatment for ROP during this extension study
- Neurodevelopmental outcomes at 2 and 5 years of age using standardized development tests (eg, Bayley Scales of Infant and Toddler Development, Third Edition [BSID-III], the Differential Ability Scales® II [DAS-II®], the Wechsler Preschool and Primary Scale of Intelligence™, Fourth Edition [WPSSI-IV], Vineland Adaptive Behavior Scales, Second Edition [VABS-II]).
- Proportion of subjects with recurrence of ROP at 3 and 5 years of age
- Proportion of subjects requiring ophthalmological treatment during this extension study
研究者
Therapeutic Area Head
Scientific
Bayer AG
研究点 (23)
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