NL-OMON38763已完成4 期
Switching to aflibercept in patients with neovascular AMD not responding to anti-VEGF treatment. - Switching non-responders to aflibercept.
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •- Patients with neovascular age-related macular degeneration (AMD) that have shown inadequate response to anti-VEGF treatment, defined as a persistant central retinal thickness on optical coherence tomography (OCT) of >=300 µm combined with a response of no greater than a reduction of 50 µm after each previous intravitreal anti-VEGF treatment.;- Patients will have received at least 6 anti-VEGF injections within 1 year. ;- Active neovascular AMD seen as leakage on fluoresceine angiography 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 (Snellen). ;- OCT available prior to first injection and after every three anti-VEGF injections.;- Give written informed consent.
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 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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