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临床试验/NCT04685369
NCT04685369已完成不适用

Effectiveness of Anti-VEGF Treatments in Wet AMD in Active Smokers

Brugmann University Hospital1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2020年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
148
试验地点
1
主要终点
Monoyer chart result

研究概览

简要总结

" Wet Age-related Macular Degeneration (wet AMD)" is characterized by the appearance of new choroidal vessels. Several clinical studies have shown the effectiveness of intra-vitreous injections of anti-VEGF (bevacizumab, ranibizumab and aflibercept) against these choroidal neovessels. However, some eyes appear to respond less well or be resistant to anti-VEGF injections, which affects visual acuity. To improve the clinical management of patients with wet AMD, it is important to be able to determine which factors determine the response to anti-VEGF treatment.

Non-modifiable factors such as visual acuity or the patient's age at the time of the first injections, the type and size of choroidal neovascularization, as well as certain genetic polymorphisms are known. Two studies, one carried out in Korean patients, the other in different centers in Singapore, New Zealand, Australia and Switzerland showed that active smoking was associated with a poorer response to intra-vitreous injections of ranibizumab, since smoking is also an already well-known modifiable risk factor for the onset of AMD. Another study in the Netherlands shows a poorer visual prognosis after five years of injection treatment in patients who smoke.

This study aims to study the effect of active smoking on the visual prognosis of patients with exudative AMD and treated with anti-VEGF injections in a Belgian cohort.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • CHU Brugmann Hospital patients
  • Patients who received three intra-vitreous injections of ranibizumab, aflibercept or bevacizumab 4 weeks apart as the first intra-vitreous treatment between January 2016 and December
  • Visual acuity measured before the start of the injections (maximum 1 month) and after the series of three injections (4 to 8 weeks after the last injection)
  • Patients whose smoking status is known and for whom the following history appears: hypertension, diabetes, taking anti-coagulants or anti-aggregants.

排除标准

  • Patients who have already received another intravitreal treatment in the past.
  • Patients who have been treated with dynamic phototherapy before or at the same time as the injections.

结局指标

主要结局

Monoyer chart result

时间窗: 4 months after baseline

Best corrected visual acuity using a monoyer chart - data collected on one eye only. Monoyer charts are planks with letters displayed: the letters in each row are the same size and the size increases as you go down.

次要结局

  • Central macular thickness(4 months after baseline)
  • Choroidal neovascularization subtype(Baseline)
  • Pigment epithelial detachment(Baseline)
  • Sub-retinal fluid(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurence Postelmans

Head of ophtalmology department

Brugmann University Hospital

研究点 (1)

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