To evaluate the Efficacy of a personalized treat-and-extend regimen of faricimab for treatment-naive polypoidal choroidal vasculopathy
Presence of active polypoidal lesions in the macula as shown by Indocyanine green angiography (ICGA) AND presence of serosanguinous maculopathy, i.e., exudative or hemorrhagic features involving the macula on color fundus photography (CFP), FA and spectral domain optical coherence tomography (SD-OCT) AND presence of IRF or SRF that affects the central subfield as seen by SD-OCT.
BCVA score must be ≤ 78 and ≥ 24 letters at 4 meters starting distance using early treatment diabetic retinopathy study (ETDRS) visual acuity charts at both Screening and Baseline.
Greatest liner dimension (GLD) of the total lesion area (branching vascular network [BVN] + polypoidal lesion) < 5400 μm (equivalent to 9 macular photocoagulation study [MPS] Disc Area) as delineated by ICGA.
Signed Informed Consent Form
Previous treatment with any anti-VEGF drugs or faricimab or investigational drugs at any time prior to Baseline.
Previous use of intraocular or periocular steroids within the 6-month period prior to Baseline.
Macular laser photocoagulation (focal/grid) or PDT at any time prior to Baseline and peripheral laser photocoagulation within 3 months prior to Baseline.
Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1
Single group
Faricimab Injection [Vabysmo]
DrugAfter 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).
The proportion of patients who reached a treatment interval of ≥16 weeks at Week 96 (LV)
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
Proportion of patients who gain ≥10 letters and ≥15 letters in best corrected visual acuity (BCVA) from baseline at Week 96.
Proportion of patients who experienced the polypoidal regression (At weeks 12, 48, 96)
Choroidal thickness (at fovea center) at Baseline, at Weeks 12 , 48, 96
Choroidal thickness is measured by optical coherence tomography
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