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.