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临床试验/NCT01993043
NCT01993043已完成不适用

Comparison of Vision and Development Outcomes in Laser- and Bevacizumab-Treated Infants With Retinopathy of Prematurity

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Vision

研究概览

简要总结

Retinopathy of prematurity (ROP) is a leading cause of childhood blindness. Vascular endothelium growth factor (VEGF) is an important component of this disease. The goal of treatment is to reduce the production of VEGF in the immature retina and to eliminate the abnormal growth of new vessels. Currently, laser photocoagulation of the peripheral avascular retina is the treatment standard. Intravitreal injection of anti-VEGF antibody Bevacizumab (IVB) has been used clinically off-label as an alternative therapy. However, VEGF is important for the development of neurons and vessels in the systemic organs in premature infants. Pharmaceutical study showed that IVB was absorbed into the bloodstream. It is unclear if the systemic absorption of Bevacizumab is dose related, and the short and longterm effects on ocular and systemic systems, especially neurological development. In this study, our goals are to establish the pharmacokinetics of Bevacizumab in the premature infant and to compare the short and long-term vision and neurodevelopmental outcomes of infants treated with IVB compared to laser ROP.

详细描述

This study will enroll preterm infants who were scheduled to receive treatment for ROP by laser or Bevacizumab. We will observe the patients in the hospital for the cure of ROP until 54 weeks' postmenstrual age. We will check the changes of chemicals in the blood and observe short-term and long-term effects on visual system, brain and other body organs. Descriptive statistics from a two sample t-test or Fisher's exact test will be used to compare the short and long-term vision and neurological development outcomes. We predefined a statistical significance level p=0.05.

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
30 Weeks 至 40 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Premature infants who were scheduled to receive laser or BEvacizumab treatment for type I ROP .

排除标准

  • Have unilateral or Bilateral ROP Stage 4 or 5 ROP;
  • Lack of signed consent by the parent or legal guardian.

结局指标

主要结局

Vision

时间窗: 5 years

Visual acuity will be measured at age of 3 and 5 years with HOTV card.

次要结局

  • The changes of neurodevelopment outcome from birth to 5 years of age(1 to 5 years old)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lingkun Kong

Principal Investigator

Baylor College of Medicine

研究点 (2)

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