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临床试验/NCT02645747
NCT02645747已完成不适用

RETRO CRVO: Retrospective Data Analysis of Patients Treated for Macular Edema Due to Central Retinal Vein Occlusion

Bayer0 个研究点目标入组 126 人开始时间: 2016年1月21日最近更新:
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
Bayer
入组人数
126
主要终点
Treatment duration

研究概览

简要总结

The objective of this retrospective chart review is to evaluate drug utilization, usage patterns and indication of effectiveness Eylea in the routine clinical (real-life) management of patients who suffer from ME (Macular Edema), secondary to CRVO (Central Retinal Vein Occlusion), and who started treatment with Eylea for this indication.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female adult patients who suffer from visual impairment due to ME secondary to CRVO
  • Anti-VEGF treatment-naive patients who started reimbursed Eylea treatment between the 1st of June 2014 and the 28th of February 2015

排除标准

  • Patients diagnosed with neovascular glaucoma secondary to CRVO will be excluded.

研究组 & 干预措施

Group 1

The source population of this study is patients who suffer from visual impairment due to ME secondary to CRVO. In order to ensure the representativeness of the study population, the number of Belgian patients which started Eylea treatment during the brief period between the 1st of June 2014 and the 28th of February 2015 were taken into account. However, data of patients diagnosed with neovascular glaucoma secondary to CRVO will be excluded.

干预措施: Aflibercept (Eylea, BAY86-5321) (Drug)

结局指标

主要结局

Treatment duration

时间窗: At 12 months of treatment with Eylea

Number of eyes treated (mono-and biocular)

时间窗: At 12 months of treatment with Eylea

Change in visual acuity (BCVA score)

时间窗: At 12 months of treatment with Eylea

Number of Eylea injections per treated eye

时间窗: At 12 months of treatment with Eylea

次要结局

  • Estimation of percentage (%) of eyes which need additional treatment after 2 years at the discretion of the treating physician.(At 12 months of treatment with Eylea)
  • Number of patients who discontinued their treatment with Eylea prematurely(At 12 months of treatment with Eylea)
  • Sufficiency of reimbursed number of Eylea injections (max. 9 injections/eye in year 1) for treatment of all patients during the first year of treatment.(At 12 months of treatment with Eylea)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

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