跳至主要内容
临床试验/NCT03115255
NCT03115255已完成不适用

Serum Concentrations of Vascular Endothelial Growth Factor in Infants Treated With Ranibizumab for Retinopathy of Prematurity

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2017年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
The effect of intravitreal ranibizumab on serum VEGF level

研究概览

简要总结

To determine the serum concentrations of ranibizumab and vascular endothelial growth factor (VEGF) in infants with retinopathy of prematurity (ROP) who received intravitreal ranibizumab

详细描述

Infants with ROP are studied. They received 0.25 mg or 0.5 mg of intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases) with vascularly active ROP. Serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab. The serum concentrations of ranibizumab and VEGF are measured by enzyme-linked immunosorbent assay, and the changes of the serum VEGF levels are determined.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
4 Weeks 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants with vascularly active ROP
  • intravitreal ranibizumab

排除标准

  • already accepted laser therapy

研究组 & 干预措施

serum VEGF level

Experimental

Serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab

干预措施: intravitreal ranibizumab (Drug)

结局指标

主要结局

The effect of intravitreal ranibizumab on serum VEGF level

时间窗: 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab

the changes of the serum VEGF levels

次要结局

  • The effect of intravitreal ranibizumab on neurologic development(corrected age of six month)
  • The effect of intravitreal ranibizumab on height(corrected age of six month)
  • The effect of intravitreal ranibizumab on weight(corrected age of six month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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