12-month outcomes of photobiomodulation in dry age-related macular degeneration: a prospective multicentre randomised double-masked controlled clinical trial

Abstract

Dry age-related macular degeneration (dAMD) is the leading cause of irreversible vision loss in older adults, with no approved treatment to modify progression in early and intermediate stages. Photobiomodulation (PBM), which targets mitochondrial dysfunction and retinal inflammation, has shown promise in early studies. This study aims to evaluate the anatomical and functional efficacy of PBM in eyes with early and intermediate dAMD. Methods: In this 12-month, multicentre, randomised double-masked controlled trial, 138 eyes from 78 patients with early or intermediate dAMD were included. The primary outcome was change in mean drusen volume (MDV) from baseline to 12 months. Secondary outcomes included change in best-corrected visual acuity (BCVA) and adverse events. Multilevel mixed-effects regression was used to analyse treatment-time interactions. Results: MDV decreased significantly in the PBM group (-0.03±0.05 mm3) while increased in the sham group (+0.02 ± 0.04 mm3; p