A prospective, open-label, single-arm, investigator-initiated clinical trial to assess the efficacy, safety and durability of faricimab in patients with inadequate response to current treatment for neovascular age-related macular degeneration: protocol design and rationale for the FURGGHORN Study.

INTRODUCTION: Anti-vascular endothelial growth factor therapy has revolutionised the treatment of neovascular age-related macular degeneration (nAMD). However, some patients face recurrent and persistent disease activity despite ongoing treatment. Faricimab (trade name: Vabysmo) is a recently approved therapy which targets two pathways involved in nAMD. This study aims to assess changes in best-corrected visual acuity (BCVA) and treatment frequency among patients currently treated for nAMD who switch to intravitreal faricimab therapy under a treat-and-extend regimen.

METHODS AND ANALYSIS: The FURGGHORN Study is a prospective, open-label, single-arm, multicentre investigator-initiated clinical trial. 102 patients with nAMD meeting inclusion criteria were recruited from 12 clinical sites across Australia and Singapore. Following 4 monthly loading doses of faricimab, treatment intervals were adjusted according to a regimen developed based on real-world practice patterns and consensus guidelines. The primary endpoint is the change from BCVA at week 52. Secondary endpoints include the proportions of patients at different treatment intervals, changes in central macular thickness and retinal fluid dimensions.

ETHICS AND DISSEMINATION: This study was designed, implemented and reported in accordance with the International Conference on Harmonisation Harmonised Tripartite Guidelines for Good Clinical Practice, with applicable local regulations and with the ethical principles laid down in the Declaration of Helsinki. Ethics approval was obtained from Bellberry Limited (2022-12-1388), St Vincent's Hospital Human Research Ethics Committee (2023/STE01568) and Singhealth Centralized Institutional Review Board (2023-2190). Results will be disseminated at scientific meetings and through peer-reviewed publications.

TRIAL REGISTRATION NUMBER: ACTRN12623000215628.