Therapeutic Prospects of Faricimab Injection for Patients Affected by Neovascular Age-Related Macular Degeneration
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorHui Peng
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
This study enrolls patients aged 50-80 years with refractory neovascular age-related macular degeneration (nAMD), defined as persistent disease activity (central subfield thickness ≥300 μm + intra-/subretinal fluid) despite ≥6 anti-VEGF injections within 12 months or ≥4 injections within 6 months. Eligible participants must have a baseline BCVA of 24-73 ETDRS letters (Snellen \~20/40-20/320) and no confounding ocular comorbidities (e.g., diabetic retinopathy, macular fibrosis) or uncontrolled systemic conditions (e.g., hypertension, diabetes). Exclusions include recent ocular surgery (\<3 months), drug hypersensitivity, or inability to comply with follow-up.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Faricimab
DrugIntravitreal injection of 6mg famotizumab into the vitreous cavity of patients with non primary wet age-related macular degeneration
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Proportion of Participants With a Valid vs. Invalid Response at 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.
Time frame
Month 6Secondary outcomes
1
Change in Best-Corrected Visual Acuity (BCVA) From Baseline
Change in BCVA as measured by ETDRS letter score.
Time frame
Baseline Month 3 Month 62
Change in Central Macular Thickness (CMT) From Baseline
Change in central macular thickness measured via OCT
Time frame
Baseline Month 3 Month 63
Change in NEI VFQ-25 Score From Baseline
Change in patient-reported visual function based on the NEI VFQ-25 (scale 0-100)
Time frame
Baseline Month 3 Month 6Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hui Peng
Lead sponsor
First Affiliated Hospital of Chongqing Medical University
Sponsor institution
Source ClinicalTrials.gov
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