跳至主要内容
临床试验/EUCTR2013-001208-12-NL
EUCTR2013-001208-12-NL进行中(未招募)1 期

Switching to aflibercept in patients with neovascular AMD not responding to anti-VEGF treatment.

Radboud University Nijmegen Medical Centre0 个研究点目标入组 20 人开始时间: 2013年5月17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
20

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

  • - Patients will have received at least 6 anti-VEGF injections within 1 year.
  • - Active neovascular AMD seen as leakage on FA and (sub-) retinal fluid on OCT.
  • - Maximally 1 year since onset of visual complaints and start of anti-VEGF treatment.
  • - Minimally 1 month and maximally 3 months between last anti-VEGF injection and first aflibercept injection.
  • - Age 50 years and older
  • - Visual acuity at baseline between 20/25 and 20/320.
  • - OCT available prior to first injection and after every three anti-VEGF injections.
  • - Give written informed consent.
  • 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 10
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • - Signs of subretinal fibrosis, scarring or geographic atrophy on OCT or FA, involving the center of the macula.
  • - Pigment epithelial detachment with a maximum height of =150µm.
  • - Any ocular diseases beside AMD in the study eye, including myopic fundus and vitreoretinal traction.
  • - Myopia of 8.00 D or more, irrespective of myopic fundus features.
  • - Ocular surgery of the study eye = 2 months prior to or during the previous anti-VEGF treatment.

研究者

发起方
Radboud University Nijmegen Medical Centre

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