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
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