POYANG: A phase III randomized clinical trial of faricimab for choroidal neovascularization secondary to pathologic myopia: study design and rationale.

PURPOSE: To describe the study design of the POYANG study, an international, randomized, double-masked, multicenter, active comparator-controlled Phase 3 trial assessing the efficacy and safety of faricimab, a dual inhibitor of angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A), in patients with choroidal neovascularization secondary to pathologic myopia (mCNV).

METHODS: Adult patients with treatment-naïve mCNV will be randomized 1:1 to receive either faricimab 6.0 mg or ranibizumab 0.5 mg. After an initial active intravitreal treatment administration at randomization (Day 1), subsequent treatment will be administered using a pro-re-nata (PRN) dosing regimen. Patients will be seen monthly over a 48-week study period and active study drug will be administered when protocol-defined retreatment criteria are met. Criteria are based on changes in best-corrected visual acuity (BCVA), central subfield thickness (CST) or examination findings consistent with mCNV activity. A sham procedure will be administered to patients at study visits when there is no active mCNV disease activity, in order to maintain masking.

RESULTS: This study aims to recruit approximately 280 patients with mCNV from 11 countries in the Asia-Pacific and European regions. The primary endpoint is non-inferiority of faricimab versus ranibizumab in change from baseline in BCVA averaged over Weeks 4, 8 and 12. Secondary endpoints include change in CST over time and number of treatments required. Incidence and severity of ocular and non-ocular adverse events will be assessed.

CONCLUSIONS: POYANG is a Phase 3 registrational trial investigating the efficacy and safety of faricimab in patients with choroidal neovascularization secondary to pathologic myopia.