To evaluate the Efficacy of a personalized treat-and-extend regimen of faricimab for treatment-naive polypoidal choroidal vasculopathy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
After applying topical anesthetic drops, intravitreal injections were delivered with a 30-gauge needle placed 3.5-4.0 mm posterior to the limbus. Patients were treated with faricimab (6 mg/0.05 ml).
Yeungnam university medical center
Daegu, Namgu, South Korea
RECRUITINGThe proportion of patients who reached a treatment interval of ≥16 weeks at Week 96 (LV)
Time frame: Week 96
Central Subfield Thickness (CST) decrease change from baseline at visit Weeks 4, 8, 12, 16, and 96 (LV)
Average retinal thickness at the central 1 mm diameter
Time frame: Week 4, week 8, week 12, week 16, week 96
Proportion of patients who gain ≥10 letters and ≥15 letters in best corrected visual acuity (BCVA) from baseline at Week 96.
Time frame: Week 96
Proportion of patients who experienced the polypoidal regression (At weeks 12, 48, 96)
Time frame: Week 12, week 48, week 96
Choroidal thickness (at fovea center) at Baseline, at Weeks 12 , 48, 96
Choroidal thickness is measured by optical coherence tomography
Time frame: Day 1, Week 12, week 48, week 96
Change in the thickness of the largest polyp and irregular pigment epithelial detachment (PED) as measured by spectral-domain OCT (SD-OCT) at Weeks 12 and 96
Time frame: Week 12, week 96
Proportion of patients with complete fluid resolution (no IRF or SRF) at Weeks 12 and 96.
Fluid shown on optical coherence tomography images
Time frame: Week 12, week 96
Mean number of injections per patient at week 48 and week 96
Time frame: Week 48, week 96
Proportion of patients who maintain their last assigned injection interval at Week 96
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Time frame: Week 96
Number of participants with treatment-related adverse events
Time frame: Through study completion, an average of 96 weeks