Neovascular age-related macular degeneration
Conditions
Interventions
Faricimab treatment group for nAMD with SHRM:None
Sponsors
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged >=50 years at the time of signing the informed consent form; 2. Treatment-naïve patients with nAMD (neovascular age-related macular degeneration) confirmed by multimodal imaging (OCT, FFA/ICGA) (treatment-naïve is defined as patients who have not received prior anti-VEGF therapy or intraocular long-acting corticosteroid sodium; including type 1, type 2, and type 3 MNV, as well as polypoidal choroidal vasculopathy [PCV]); 3. Chinese population; 4. Only patients who have already been scheduled to receive faricimab therapy during outpatient visits (i.e., prior to study entry) are eligible, and this treatment decision must be made independently of the study; 5. Baseline SD-OCT scans show the presence of fovea-involving SHRM (subretinal hyperreflective material) with a maximum height of >=50 µm; 6. Clear ocular media, sufficient to obtain high-quality OCT and OCTA images; 7. Written informed consent has been signed.
Exclusion criteria
Exclusion criteria: 1. MNV (macular neovascularization) secondary to other causes, such as high myopia, inflammation, or trauma; 2. Any prior intraocular surgery (e.g., vitrectomy) in the study eye, except for uncomplicated cataract surgery performed more than 3 months prior to the study; 3. Concomitant with other retinal vascular diseases that may affect macular morphology, such as diabetic retinopathy or retinal vein occlusion; 4. Concomitant with active endophthalmitis, uveitis, or uncontrolled glaucoma; 5. Presence of extensive subretinal hemorrhage at baseline (occupying greater than 50% of the lesion area) that obscures the boundaries of the SHRM, making accurate segmentation and analysis impossible; 6. Presence of fovea-involving RPE (retinal pigment epithelium) tear at baseline; 7. History of idiopathic or autoimmune-related uveitis in either eye; 8. Active ocular inflammation, or suspected or active ocular or periocular infection in either eye; 9. Patients with a known allergy or hypersensitivity to any study drugs or contrast agents, such as faricimab, sodium fluorescein, or indocyanine green; 10. Concomitant with severe systemic diseases (such as poorly controlled cardiovascular or cerebrovascular diseases, liver or kidney failure, active infections, etc.), or patients deemed unsuitable for enrollment by the investigator's judgment; 11. Poor image quality that fails to meet the requirements for quantitative analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in SHRM volume; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual improvement of SHRM patients with Faricimab; | — |
Countries
China
Contacts
Public ContactWen Feng
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Outcome results
None listed