This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled study evaluating the efficacy and safety of faricimab in patients with myopic choroidal neovascularization (CNV). This non-inferiority study will compare 6.0 mg faricimab versus 0.5 mg ranibizumab administered at a pro-re-nata (PRN) dosing regimen after an initial active IVT treatment administration at randomization (Day 1).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Treatment-naïve choroidal neovascularization (CNV) secondary to myopia
✓. Diagnosis of active myopic CNV in the study eye:
✓. Presence of high myopia, worse than -6 diopters of spherical equivalence
✓. Antero-posterior elongation measurement greater than or equal to 26.0 mm
✓. Presence of posterior changes compatible with pathologic myopia (e.g., tessellated fundus, lacquer cracks, etc.)
✓. Presence of active leakage from CNV on FFA (determined by Central Reading Centre \[CRC\])
✓. Presence of intraretinal or subretinal fluid or increase of CST on OCT (determined by CRC)
✓. BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol on Day 1
Exclusion criteria
✕. Any major illness or major surgical procedure within 1 month before screening
✕. Pregnancy or breastfeeding, or intention to become pregnant during the study or within 3 months after the final study treatment administration
✕. History of systemic or ocular disease that would contraindicate treatment with the investigational drug or comparator
✕. Uncontrolled glaucoma in study eye
✕. Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities, including, but not restricted to, intravitreal, periocular or laser interventions in study eye
✕. Prior or concomitant periocular or intravitreal pharmacological treatment, including anti-VEGF medication, for other retinal diseases (e.g. geography atrophy, nAMD, DME etc.) in study eye