LIGHTSITE III: 13-Month Efficacy and Safety Evaluation of Multiwavelength Photobiomodulation in Nonexudative (Dry) Age-Related Macular Degeneration Using the Lumithera Valeda Light Delivery System

• Published in: Retina (Philadelphia, Pa.) Vol. 44; no. 3; p. 487
• Main Authors: Boyer, David, Hu, Allen, Warrow, David, Xavier, Samantha, Gonzalez, Victor, Lad, Eleonora, Rosen, Richard B, Do, Diana, Schneiderman, Todd, Ho, Allen, Munk, Marion R, Jaffe, Glenn, Tedford, Stephanie E, Croissant, Cindy L, Walker, Michael, Rückert, Rene, Tedford, Clark E
• Format: Journal Article
• Language: English
• Published: United States 01.03.2024
• Subjects: Eye; Geographic Atrophy - diagnosis; Geographic Atrophy - radiotherapy; Humans; Low-Level Light Therapy; Macular Degeneration - diagnosis; Macular Degeneration - drug therapy; Macular Degeneration - radiotherapy; Prospective Studies; Visual Acuity
• DOI: 10.1097/IAE.0000000000003980

The LIGHTSITE III study evaluated multiwavelength photobiomodulation (PBM) therapy in nonexudative (dry) age-related macular degeneration (AMD) using the LumiThera Valeda Light Delivery System. LIGHTSITE III is a randomized, controlled trial to assess the safety and effectiveness of PBM in dry AMD. Subjects were given multiwavelength PBM (590, 660, and 850 nm) or Sham treatment delivered in a series of nine sessions over 3 to 5 weeks every four months over 24 months. Subjects were assessed for efficacy and safety outcomes. Data from the 13-month analysis are presented in this report. A total of 100 subjects (148 eyes) with dry AMD were randomized. LIGHTSITE III met the primary efficacy best-corrected visual acuity endpoint with a significant difference between PBM (n = 91 eyes) and Sham (n = 54 eyes) groups (Between group difference: 2.4 letters (SE 1.15), CI: -4.7 to -0.1, P = 0.02) (PBM alone: 5.4 letters (SE 0.96), CI: 3.5 to 7.3, P < 0.0001; Sham alone: 3.0 letters (SE 1.13), CI: 0.7-5.2, P < 0.0001). The PBM group showed a significant decrease in new onset geographic atrophy ( P = 0.024, Fisher exact test, odds ratio 9.4). A favorable safety profile was observed. LIGHTSITE III provides a prospective, randomized, controlled trial showing improved clinical and anatomical outcomes in intermediate dry AMD following PBM therapy.