跳至主要内容
临床试验/NCT02091505
NCT02091505Unknown不适用

Predictive Factors of Treatment Outcome After Intravitreal Injection of Lucentis (Ranibizumab) in Eyes With Macular Edema Associated With Central Retinal Vein Occlusion (CRVO)

Mie University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年12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
入组人数
30
试验地点
1
主要终点
Best-corrected visual acuity

研究概览

简要总结

Recent studies have shown that intravitreal injection of anti-VEGF agent, Lucentis (Ranibizumab) is effective for macular edema associated with central retinal vein occlusion (CRVO). However, there is little information on whether there are any predictive factors of treatment outcome after this treatment. We plan to perform comprehensive functional and imaging tests to determine significant predictive factors.

详细描述

The purpose of the present study is to investigate predictive factors of treatment outcome after intravitreal injection of Lucentis (Ranibizumab) in eyes with macular edema associated with central retinal vein occlusion (CRVO) using various comprehensive clinical tests including visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, new flicker electroretinogram (ERG) using skin electrodes. Corrected visual acuity, visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, and new flicker electroretinogram (ERG) using skin electrodes are performed before and 3, 6, 9, 12 months after the treatment. Predictive factors of treatment outcome are statistically analyzed.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Macular edema associated with central retinal vein occlusion
  • Best corrected visual acuity < 20/30
  • Central macular thickness > 300
  • Period from symptom onset to treatment < 12 months

排除标准

  • Any past history of treatment for macular edema (e.g. anti-VEGF injection, steroid, vitrectomy)

研究组 & 干预措施

Intravitreal injection of Ranibizumab

Experimental

干预措施: Ranibizumab (Drug)

结局指标

主要结局

Best-corrected visual acuity

时间窗: 12 months

次要结局

未报告次要终点

研究者

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

Mineo Kondo

MD. PhD.

Mie University

研究点 (1)

Loading locations...

相似试验