Photobiomodulation for dry age-related macular degeneration: A prospective, real-world assessment of visual and retinal outcomes at 12 months of follow-up

Purpose To evaluate longitudinal changes in visual function and retinal anatomical parameters over 12 months in eyes undergoing photobiomodulation (PBM) across the AREDS severity spectrum. Methods: This prospective, single-center, exploratory real-world study included consecutive patients undergoing PBM using the Valeda® Light Delivery System. Best-corrected visual acuity (BCVA) and multimodal imaging were assessed longitudinally over 12 months. Changes in BCVA, central macular thickness (CMT), and subfoveal choroidal thickness (ChT) were evaluated using linear mixed-effects models accounting for repeated measurements and bilateral inclusion. Results The longitudinal analysis included 108 eyes from 81 participants (mean age, 74.0 ± 10.4 years). At Month 12, the model-estimated mean BCVA change from baseline was +1.7 ETDRS letters (95% CI, 0.5 to 3.0). Twenty-five eyes (23.2%) gained ≥5 letters, 74 (68.5%) remained within ±4 letters, and 9 (8.3%) lost ≥5 letters. Eyes with baseline BCVA ≤70 letters showed a larger descriptive mean change (+5.4 letters) than eyes with BCVA >70 letters (−0.6 letters), although this comparison is susceptible to ceiling effects and regression to the mean. CMT showed a small reduction at Month 12 (−4.6 µm; 95% CI, −8.2 to −0.9), whereas ChT showed no sustained change. One treated eye developed neovascular AMD after the first PBM cycle. Conclusions Modest longitudinal improvement in BCVA was observed following PBM treatment in this real-world cohort. Greater numerical gains among eyes with lower baseline BCVA should be interpreted cautiously because of regression to the mean and the absence of a control group. Anatomical changes were small and of uncertain clinical relevance. Controlled studies are required to determine whether these observations represent a treatment effect.