Therapeutic Prospects of Faricimab Injection for Patients Affected by Neovascular Age-Related Macular Degeneration
- Conditions
- Neovascular Age-related Macular Degeneration(nAMD)
- Registration Number
- NCT07088445
- Lead Sponsor
- Hui Peng
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 35
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of Participants With a Valid vs. Invalid Response at Month 6 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.
- Secondary Outcome Measures
Name Time Method Change in Best-Corrected Visual Acuity (BCVA) From Baseline Baseline Month 3 Month 6 Change in BCVA as measured by ETDRS letter score.
Change in Central Macular Thickness (CMT) From Baseline Baseline Month 3 Month 6 Change in central macular thickness measured via OCT
Change in NEI VFQ-25 Score From Baseline Baseline Month 3 Month 6 Change in patient-reported visual function based on the NEI VFQ-25 (scale 0-100)