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临床试验/NCT07390253
NCT07390253进行中(未招募)不适用

Aflibercept 8mg in Patients Diagnosed With Neovascular Age-related Macular Degeneration (AMD) Who Have Been Treated With Aflibercept 2mg: the Eylea 8mg Switch Study

Vienna Institute for Research in Ocular Surgery1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年9月18日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50
试验地点
1
主要终点
Number of intravitreal injections

研究概览

简要总结

This study will investigate if switching patients who appear to be sub-optimal responders to the current standard of care treatment with Aflibercept 2mg to Aflibercept 8mg will prolong treatment intervals and maintain visual acuity.

详细描述

Aflibercept 8 mg was recently approved by the European Medicines Agency (EMA) for the treatment of neovascular age-related macular degeneration (nAMD). The higher dosage promises prolongation of treatment intervals up to 16 weeks. Only limited clinical data is available on switching from so-called suboptimal or non-responders. A retrospective analysis showed that aflibercept in 3 mg or 4 mg doses can improve outcomes in patients who do not respond optimally to aflibercept 2 mg. It remains unclear whether switching to the above-mentioned and newly approved aflibercept 8 mg will prolong treatment intervals and stabilize visual acuity in patients who are not treatment-naive.

The present study is a single-center observational study. The plan is to include 50 eyes from 50 patients who have previously received aflibercept 2 mg injections. Patients receive a routine 8 mg aflibercept injection in the eye clinic based on the existing treat-extend regimen. At each visit, a visual acuity test, optical coherence tomography (OCT) imaging, and a standard slit lamp examination with fundoscopy are performed. The injection interval is extended by two weeks. If the two-week extension leads to deterioration, the interval is shortened by two weeks. Patients are monitored in the study for 12 months.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
21 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients, who received prior intravitreal anti-VEGF-treatment for nAMD with Aflibercept 2mg. A minimum of four injections of Aflibercept 2mg is required. Therefore 16-24 weeks prior treatment with anti-VEGF is required in line with an interval of 4-8 weeks.
  • Short treatment intervals of 4 or 8 weeks
  • Age 21 or older
  • Written informed consent

排除标准

  • Chronic treatment with Bevacizumab or Faricimab
  • Extensive macular fibrosis
  • Diabetic retinopathy
  • Other retinal pathologies (e.g. retinal vein occlusion)
  • Dense media opacities (cataract, corneal scars)
  • Vitreous hemorrhage
  • Ocular or periocular infections
  • Active intraocular inflammation
  • Hypersensitivity to the active substance or to any of the excipients
  • Prior Aflibercept 8mg treatment
  • Pregnancy (for women in reproductive age a pregnancy test will be performed)

研究组 & 干预措施

neovascular age-related macular degeneration (nAMD)

Patient suffering from neovascular age-related macular degeneration (nAMD)

干预措施: Aflibercept (Drug)

结局指标

主要结局

Number of intravitreal injections

时间窗: 12 months

Total number of intravitreal injections will be assessed over 12 months

次要结局

  • corrected distance visual acuity (CDVA)(12 months)
  • Central retinal thickness (CRT)(12 months)
  • Intraretinal fluid (IRF)(12 months)

研究者

发起方
Vienna Institute for Research in Ocular Surgery
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Vienna Institute for Research in Ocular Surgery

研究点 (1)

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