Glenn J. Jaffe, David Boyer, Allen Y. Hu, David Warrow, Samantha Xavier, Victor Gonzalez, Eleonora Lad, Richard B. Rosen, Diana V. Do, Todd E. Schneiderman, Allen C. Ho, Marion Rohit Munk, Stephanie E. Tedford, Cindy L. Croissant, René Rückert, Phil Lavin, Clark E. Tedford
PURPOSE: To evaluate the safety and efficacy of multiwavelength photobiomodulation (PBM) in nonexudative (dry) age-related macular degeneration (AMD). METHODS: LIGHTSITE III used a double-masked, randomized, sham-controlled, parallel-group, prospective study design. Subjects were enrolled with a diagnosis of dry AMD and treated with multiwavelength PBM (Valeda Light Delivery System; 590, 660, and 850 nm) or sham treatment. A treatment series included 9 PBM or sham treatments delivered 3x/week over 3 to 5 weeks every 4 months (M) for 24M. RESULTS: A total of 148 eyes (100 subjects) with dry AMD were randomized into the study. LIGHTSITE III met the prespecified primary BCVA efficacy end point at M21 with a significant difference between treatment groups ( P = 0.0036) and a +6.2 letter gain after PBM. At M21, 61.5% of PBM-treated eyes showed ≥5, 23.1% showed ≥10, and 4.4% showed ≥15 letter gains. A favorable safety profile was observed with no signs of phototoxicity. Disease progression to Geographic Atrophy (GA) showed a significant decrease in incidence (Sham, 24.0% vs. PBM, 6.8%; P = 0.007) after PBM treatment at M24. Significant benefit in vision QoL was observed. CONCLUSION: Multiwavelength PBM represents an interventional therapy that restores visual function and has potential disease-modifying effects in intermediate dry AMD.