Abstract
Background:
Photobiomodulation Valeda (PBM-Valeda) is a novel therapeutic approach for dry age-related macular degeneration (AMD). The primary objective of this short-term study was to conduct an analysis of best-corrected visual acuity (BCVA) and evaluate of biomarkers using state-of-the-art high-resolution imaging with swept-source optical coherence tomography OCT (SS-OCT) and OCT angiography (SS-OCTA) in dry AMD patients treated with PBM.
Materials and Methods:
This prospective, noncomparative, interventional case series pilot study examined the following biomarkers before and after PBM treatment: BCVA, central macular thickness (CMT), subfoveal choroidal thickness (SCT), capillary density (CD), avascular area of the superficial plexus (AASP), and avascular area of the deep plexus (AADP). All parameters were assessed at baseline and 1 week after treatment. A questionnaire (exploratory, not a validated endpoint) was carried out at the end of the treatment.
Results:
The study included 25 eyes (19 patients), predominantly in the Age-Related Eye Disease Study category II. A statistically significant change in BCVA was observed (p = 0.001). No statistically significant changes were observed in CMT, SCT, CD, AASP, or AADP (p > 0.05). The treatment was well tolerated, with few mild side effects, and no patient developed wet AMD.
Conclusion:
PBM-Valeda therapy demonstrated a favorable short-term safety profile in patients with dry AMD. The key finding of this study was the stability of SS-OCT and SS-OCTA biomarkers (CMT, SCT, CD, AASP, and AADP), with no adverse changes observed. These results reinforce the short-term safety of PBM. Reported side effects were minimal, with no evidence of retinotoxicity. This is the first prospective study to explore SS-OCT and SS-OCTA biomarkers in patients with dry AMD undergoing PBM therapy, providing preliminary safety data for future controlled trials.