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临床试验/NCT04955171
NCT04955171Unknown3 期

Outcome of Brolucizumab-dbll and Aflibercept Intravitreal Injection in the Treatment of Diabetic Macular Edema

Benha University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
60
试验地点
1
主要终点
Best corrected visual acuity (BCVA)

研究概览

简要总结

Diabetic macular edema degeneration occur is a vision threatening condition. The investigators compare the efficacy of BEOVU and Eylea intravitreal treatment in the management

详细描述

Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination was done. Procedure included randomized intravitreal injection of Brolucizumab(BEOVU®, Genentech, South Francisco, CA) and of aflibercept (Eylea;Regeneron, Tarrytown,NY)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • Diabetic macular edema

排除标准

  • other causes of macular edema
  • other macular diseases

研究组 & 干预措施

BEOVU

Active Comparator

Intravitreal injection of BEOVU 3 loading injections( monthly) then under treat and extent regimen

干预措施: BEOVU intravitreal injection (Drug)

Eylea

Active Comparator

Intravitreal injection of Eylea 3 loading injections( monthly) then under treat and extent regimen

干预措施: BEOVU intravitreal injection (Drug)

结局指标

主要结局

Best corrected visual acuity (BCVA)

时间窗: 12 months

Change in BCVA in LOG MARS(logarithm minimum angle of resolution

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

Tarek Roshdy mohamed Mahgoub ELhamaky

Associate Professor

Benha University

研究点 (1)

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