Therapeutic Prospects of Faricimab Injection for Patients Affected by Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 主要终点
- Proportion of Participants With a Valid vs. Invalid Response at Month 6
研究概览
简要总结
Neovascular Age-Related Macular Degeneration (nAMD) is one of the main causes of irreversible vision loss in the elderly, characterized by neovascularization and vascular leakage in the macular area, ultimately leading to damage to retinal structure and visual impairment. At present, anti vascular endothelial growth factor (VEGF) therapy is the main approach for treating nAMD, including VEGF inhibitors such as Aflibercept and Conbercept. However, some patients show decreased treatment tolerance or efficacy after long-term use of these drugs . Faricimab, a bispecific antibody that targets both VEGF and angiopoietin-2 (Ang-2), is expected to provide a new treatment option for patients resistant to existing VEGF therapies due to its unique dual mechanism of action The aim of this study is to explore the treatment response rate and prognosis of farnesyl monoclonal antibody in patients with refractory nAMD, including visual improvement and imaging changes, in order to provide more scientific treatment decision-making basis for clinical practice. At the same time, to determine its efficacy and safety in actual clinical treatment, in order to provide more flexible and personalized treatment options for nAMD patients, reduce their treatment burden, improve treatment compliance and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of wet age-related macular degeneration (nAMD) in individuals aged 50 years to 80 years.
- •Refractory nAMD: ≥ 6 injections of anti VEGF drugs within 12 months or ≥ 4 injections within 6 months, CFT ≥300 μm， In addition, there is retinal fluid.
- •BCVA is 24 to 73 letters (equivalent to Snellen vision of about 20/40 to 20/320) in the early treatment of diabetes retinopathy study (ETDRS) scoring scale.
- •The subjects can understand the purpose of the study and voluntarily sign a written informed consent.
排除标准
- •Accompanied by other eye diseases that may affect the structure or function of the macula (such as diabetes retinopathy, uveitis, etc.). There are obvious scars or fibrosis on the vitreous or retina.
- •There is uncontrolled hypertension, diabetes or other systemic diseases that may affect the treatment effect.
- •Having undergone eye surgery (such as retinal laser treatment or vitrectomy) and less than 3 months after surgery.
- •Allergic to farnesyl monoclonal antibody or its components.
- •Patients who are unable to complete follow-up or have poor compliance.
- •Researchers determine other factors that may affect the safety or data integrity of the experiment.
结局指标
主要结局
Proportion of Participants With a Valid vs. Invalid Response at Month 6
时间窗: Month 6
① Valid response: a. Good response: No IRF, SRF, and ≥75% reduction in CMT; b. Partial response: Persistent IRF/SRF with a 25-75% reduction in CMT. ② Invalid response: a. Poor response: Persistent or new IRF/SRF with a 0-25% reduction in CMT; b. No response: IRF, SRF, and/or PED remain unchanged or increased.
次要结局
- Change in Best-Corrected Visual Acuity (BCVA) From Baseline(Baseline Month 3 Month 6)
- Change in Central Macular Thickness (CMT) From Baseline(Baseline Month 3 Month 6)
- Change in NEI VFQ-25 Score From Baseline(Baseline Month 3 Month 6)
研究者
Hui Peng
Chief physician
First Affiliated Hospital of Chongqing Medical University