A Multicenter Real-life Observational Retrospective Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With Refractory or Dependent Exudative AMD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Difference in number of weeks between previous treatment (ranibizumab or aflibercept) and after 6 months of Faricimab treatment.
研究概览
简要总结
Age-related macular degeneration (AMD) is a degenerative retinal disease. The prognosis of the exudative form was transformed by the introduction of the anti-VEGF monoclonal antibody treatments ranibizumab [1] and aflibercept [2] in the 2010s. In 2022, a new molecule, Faricimab, proved its efficacy in exudative AMD. It is a bi-specific monoclonal antibody against VEGF-A and ANG2. The drug has been granted marketing authorization in France, with reimbursement due to begin in October 2023 for naïve patients as well as for those already treated with ranibizumab or aflibercept. The main advantage of this compound [3] is that it extends the injection interval in the Treat and Extend (T&E) protocol, which is more extensive than with previous anti-VEGF agents.
The patients included in the faricimab Phase III study were all naïve to any anti-VEGF treatment. In practice, faricimab is likely to offer hope to patients already treated with anti-VEGF with a short injection interval to lengthen the number of weeks between injections.
As the treatment will be on sale in pharmacies from October 2023, a switch study from previous anti-VEGF drugs to faricimab would contribute to an initial real-life evaluation of the drug in this indication.
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
- 否
入选标准
- •Male or female patient of legal age (≥18 years) with exudative AMD treated with IVT ranibizumab or aflibercept > 1 year.
- •Patient whose IVT injection interval is strictly less than 12 weeks.
排除标准
- •Severe myopia (axial length > 26 mm or sphere < - 6 dioptres).
- •Presence of angioid striae.
- •Presence of moderate or more severe diabetic retinopathy.
- •History of diabetic macular edema.
- •History of uveitis.
- •Previous retinal vein occlusion (branch or central vein).
- •History of pseudovitelliform macular dystrophy.
- •Patient under guardianship or trusteeship
- •Pregnant or breast-feeding woman
结局指标
主要结局
Difference in number of weeks between previous treatment (ranibizumab or aflibercept) and after 6 months of Faricimab treatment.
时间窗: 1 year
number of week
次要结局
- Difference between time to recurrence before switch and after switch.(1 year)