LIGHTSITE II Randomized Multicenter Trial: Evaluation of Multiwavelength Photobiomodulation in Non-exudative Age-Related Macular Degeneration

• DOI: 10.1007/s40123-022-00640-6
• Publication Date: 2023-01-02T04:22:10Z
• Authors: Ben Burton; Maurizio Battagli...; Ignasi Jürgens; Xavier Zanlonghi; Dan Hornan; Johann Roider; Katrin Lorenz; Marion R. Munk; Cindy L. Croissant; Stephanie E. Tedford; Michael Walker; Rene Ruckert; Clark E. Tedford
• Keywords: 0301 basic medicine; Vision; 610 Medicine & health; Photobiomodulation; RE1-994; Ocular disease; Mitochondria; 3. Good health; Multiwavelength; Ophthalmology; 03 medical and health sciences; Age related macular degeneration; Original Research

Photobiomodulation (PBM) represents a potential treatment for non-exudative age-related macular degeneration (AMD). PBM uses wavelengths of light to target components the mitochondrial respiratory chain improve cellular bioenergetic outputs. The aim this study was further investigate effects on clinical, quality life (QoL) and anatomical outcomes in subjects with intermediate stage AMD. multicenter LIGHTSITE II randomized clinical trial evaluating safety efficacy LumiThera Valeda® Light Delivery System delivered multiwavelength (590, 660 850 nm) or sham 3 × per week over 3–4 weeks (9 treatments series) repeated at baseline (BL), 4 8 months. Subjects were enrolled 20/32 20/100 best-corrected visual acuity (BCVA) no central geographic atrophy (GA) within fovea (500 μm). 44 AMD (53 eyes). PBM-treated eyes showed statistically significant improvement BCVA 9 months (n = 32 eyes, p 0.02) 4-letter gain group versus 0.5-letter sham-treated (ns, < 0.1) patients that received all 27 29 Approximately 35.3% ≥ 5-letter Macular drusen volume not increased time but did show increases group. While groups both GA lesion growth period, there 20% less 10 months, suggesting disease-modifying effects. No concerns signs phototoxicity observed. These results confirm previous testing support Valeda as novel therapy unique mechanism action Clinicaltrial.Gov Registration Identifier: NCT03878420.