Comparison of the Vascular Endothelial Growth Factor Serum Concentrations After Intravitreal Use of Bevacizumab or Ranibizumab as a Treatment for Type 1 Retinopathy of Prematurity
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To compare the serum VEGF concentrations after intravitreal application of Bevacizumab vs Ranibizumab
研究概览
简要总结
The Retinopathy of Prematurity (ROP) is one of the leading causes of blindness on the pediatric age worldwide. This pathology is characterized for arrest of the normal vascular and neuronal retina that because of pathological compensatory mechanisms results in proliferation of vascular tissue that grow in the limit between the vascular retina and the avascular retina.
The ET-ROP group classified the ROP by those who need treatment immediately or those who doesn't need treatment, The classification is the following Type 1 ROP-->ROP zone I any stage with plus, zone I stage 3 without plus, zone II stage 2 y 3 with plus Type 2 ROP --> Zone 1, Stage 2 or 3 without plus, and Zone II, stage 3 without plus.
The treatment is begun on patient with type 1 ROP and type 2 ROP is maintained in observation.
详细描述
It has been documented that de Vascular Endothelial Growth Factor (VEGF) is involved on the physiopathology of this disease.
The VEGF is a glucoprotein that regulates the angiogenesis and the vasculogenesis, it's presence is crucial on the growth and development of several tissues around the organism.
Nowadays the treatment of type 1 ROP it si focus on the disminution of the intravitreal VEGF after the intravitreal application of drugs like Bevacizumab and Ranibizumab.
However these drugs can pass through the hematorretinal barrier in to the blood stream where they can also decrease the systemic levels of VEGF.
We still don't know the long term effects of the intravitreal application of these drugs on premature babies, but there is the concern.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The principal investigator and the outcomes assesor will be blinded, the assignation of the treatment will be randomized. The parents or tutor of the participant will be blinded
入排标准
- 年龄范围
- 28 Days 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature newborns that fulfill the criteria for type 1 ROP, according to the Early Treatment of ROP classification on both eyes.
排除标准
- •Patients that do not continue the required evaluations.
研究组 & 干预措施
Bevacizumab injection
Application of Intravitreal Bevacizumab (0.50mg/0.02mL), unique dosis
干预措施: Bevacizumab Injection (Drug)
Ranibizumab Ophthalmic
Application of Intravitreal Ranibizumab (0.25mg/0.025mL), unique dosis
干预措施: Ranibizumab Ophthalmic (Drug)
结局指标
主要结局
To compare the serum VEGF concentrations after intravitreal application of Bevacizumab vs Ranibizumab
时间窗: 6 months
Evaluate the Serum VEGF concentration with the ELISA assay after intravitreal application of Bevacizumab or ranibizumab
次要结局
未报告次要终点
研究者
Ada Gabriela Hernández Gámez
MD
Universidad Autonoma de San Luis Potosí