Intravitreal Ranibizumab to Treat Retinopathy of Prematurity Stage 3 Plus Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- number of eyes with ocular side effects due to intravitreal ranibizumab
研究概览
简要总结
Retinopathy of prematurity (ROP) is a neovascular retinal disorder of premature born children, characterized by the development of retinal neovascularisation, macular dragging and eventually retinal detachment. ROP is a leading cause for childhood blindness, especially in developing countries. Vascular endothelial growth factor (VEGF) plays an important role in the development of the disease. Recently, the BEAT ROP study tested the efficacy of intravitreal bevacizumab for stage 3 plus ROP in a prospective, controlled, randomized, stratified, multicenter trial. Authors found that bevacizumab showed a significant benefit for Zone I but not Zone II disease, with continuation of peripheral retinal vessel growths after treatment. The authors also concluded that safety could not be assessed due to the small sample size. Other authors raised concerns regarding the results of the BEAT ROP study and the safety of bevacizumab.
The investigators suspected a better safety profile for ranibizumab to treat stage 3 plus ROP. Here we present the outcome of 6 eyes with ROP stage 3 plus treated with a single injection of ranibizumab.
详细描述
The outcome of six eyes with ROP stage 3 plus treated with one single intravitreal injection of ranibizumab is presented. Safety issues and side affects are discussed. Follow up was 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 32 Weeks 至 40 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ROP stage 3 plus disease
排除标准
- •Severe systemic co-morbidity that did not allow systemic sedation for injection, or were antiVEGF (vascual endothelial growth factor) therapy was contra-indicated
研究组 & 干预措施
Ranibizumab
All eyes receive one intravitreal injection with 0.03ml ranibizumab
干预措施: intravitreal injection of 0.03ml ranibizumab (Drug)
结局指标
主要结局
number of eyes with ocular side effects due to intravitreal ranibizumab
时间窗: 6 months
assessment of direct ocular adverse events due to intravitreal ranibizumab injections as a measure of safety
次要结局
- number of patients with systemic side effects of intravitreal ranibizumab(6 months)
- efficacy of intravitreal ranibizumab to treat ROP stage 3 plus(6 months)
研究者
Marcel Menke
PD Dr. med univ. Marcel N Menke
Kantonsspital Aarau
