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临床试验/EUCTR2013-005056-15-BE
EUCTR2013-005056-15-BE进行中(未招募)1 期

ongterm efficiency and safety of intravitreal injections with bevacizumab in patients with neovascularisation or macular edema.

Z Gent0 个研究点目标入组 800 人开始时间: 2014年2月20日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
800

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1.Age = 18 years of either gender
  • 2.Written informed consent must be obtained before any intravitreal injection of bevacizumab is performed
  • 3.Visual impairment predominantly due to abnormal new vessel ingrowth and/or macular edema. The prescence of fluid (intraretinal, subretinal or sub-RPE) detected clinically or on the OCT.
  • If both eyes are eligible for the study, both eyes can be included in the study
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 400
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 400

排除标准

  • 1.Women who are pregnant or breastfeeding (pregnancy defined as the state of a female after conception until the termination of gestation, confirmed by a positive hCG laboratory test (> 5mIU/mL)
  • Women of child bearing potential must be practicing effective contraception implemented during the trial and for at least 28 days following the last dose of study medication
  • 2.Tromboembolic event (CVA or TIA, AMI) less than 3 months prior to the intravitreal injection of bevacizumab
  • 3.History of hypersensitivity for bevacizumab.

研究者

发起方
Z Gent

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