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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faricimab | Drug | Intravitreal injection of 6mg famotizumab into the vitreous cavity of patients with non primary wet age-related macular degeneration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best-Corrected Visual Acuity (BCVA) From Baseline | Change in BCVA as measured by ETDRS letter score. | Baseline Month 3 Month 6 |
| Change in Central Macular Thickness (CMT) From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xuefeng qin | Contact | 86+17772307246 | 846824618@qq.com |
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IPD will not be shared due to concerns regarding patient privacy, the limited scope of data use consent obtained from participants, and institutional policies restricting public data disclosure. Additionally, the current study does not have the infrastructure in place to support secure data sharing and oversight.
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| ID | Term |
|---|---|
| C000723200 | faricimab |
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Change in central macular thickness measured via OCT
| Baseline Month 3 Month 6 |
| Change in NEI VFQ-25 Score From Baseline | Change in patient-reported visual function based on the NEI VFQ-25 (scale 0-100) | Baseline Month 3 Month 6 |