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Evaluate the benefit of faricimab (4 loading doses + PRN) on best-corrected visual acuity in patients with nAMD. Evaluate the safety and anatomical improvement of faricimab (4 loading doses + PRN) in patients with nAMD.
This study is a prospective, single-arm, observational study designed to evaluate the efficacy and safety of faricimab (4 loading doses + PRN) in patients with neovascular age-related macular degeneration (nAMD). Patients first receive four intravitreal loading injections of faricimab (6 mg each) at 4-week intervals, followed by a pro re nata (PRN) treatment phase. The study assesses changes from baseline in best-corrected visual acuity (BCVA), contrast sensitivity, choroidal vascularity index (CVI), maximum pigment epithelial detachment (PED) height, and the proportion of patients with intraretinal fluid (IRF) / subretinal fluid (SRF) at weeks 4, 8, 12, 16, 24, and 48. The objective is to evaluate the visual benefit, anatomical improvement, and safety of faricimab (4 loading doses + PRN) in treating nAMD. The use of other anti-VEGF agents (systemic or ocular) is prohibited during the treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neovascular Age-related Macular Degeneration(nAMD) Group |
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| Measure | Description | Time Frame |
|---|---|---|
| Choroidal Vascularity Index (CVI) | CVI represents the proportion of the total choroidal area occupied by blood vessels (luminal area). | Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| visual contrast sensitivity | Visual contrast sensitivity is the ability to detect differences in luminance (brightness) between an object and its background. | Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks |
| Height of pigment epithelial detachment |
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Inclusion Criteria:
Exclusion Criteria:
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The study subjects were recruited from outpatients of the Medical Retina Department at Zhongshan Ophthalmic Center, and eligible cases meeting the study criteria were selected from the outpatient medical record system.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rongtian Chen | Contact | 16619724130 | 376126340@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Chenjin Jin | Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong 510060 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong | 510060 | China |
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The vertical distance between the detached retinal pigment epithelium (RPE) and the underlying Bruch's membrane. |
| Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks |