Aflibercept 8mg in Patients Diagnosed With Neovascular Age-related Macular Degeneration (AMD) Who Have Been Treated With Aflibercept 2mg: the Eylea 8mg Switch Study
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
- 否
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
Prim. Prof. Dr. Oliver Findl, MBA
Principal Investigator
Vienna Institute for Research in Ocular Surgery
