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临床试验/NCT02164604
NCT02164604已完成不适用

Intravitreal Ranibizumab to Treat Retinopathy of Prematurity Stage 3 Plus Disease

Kantonsspital Aarau1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2011年1月最近更新:
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
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

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

Experimental

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

发起方
Kantonsspital Aarau
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcel Menke

PD Dr. med univ. Marcel N Menke

Kantonsspital Aarau

研究点 (1)

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