Boyer, DavidDavidBoyerHu, AllenAllenHuWarrow, DavidDavidWarrowXavier, SamanthaSamanthaXavierGonzalez, VictorVictorGonzalezLad, EleonoraEleonoraLadRosen, Richard BRichard BRosenDo, DianaDianaDoSchneiderman, ToddToddSchneidermanHu, AllenAllenHuMunk, Marion RMarion RMunkJaffe, GlennGlennJaffeTedford, Stephanie EStephanie ETedfordCroissant, Cindy LCindy LCroissantWalker, MichaelMichaelWalkerRückert, ReneReneRückertTedford, Clark EClark ETedford2024-10-252024-10-252024-03-01https://boris-portal.unibe.ch/handle/20.500.12422/171510PURPOSE The LIGHTSITE III study evaluated multiwavelength photobiomodulation (PBM) therapy in nonexudative (dry) AMD using the LumiThera Valeda® Light Delivery System. METHODS LIGHTSITE III is a randomized, controlled trial to assess the safety and effectiveness of PBM in dry AMD. Subjects were treated with multiwavelength PBM (590, 660 and 850 nm) or Sham treatment delivered 9 treatments over 3-5 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. RESULTS A total of 100 subjects (148 eyes) with dry AMD were randomized. LIGHTSITE III met the primary efficacy BCVA 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 - -0.1, p = 0.02)(PBM alone: 5.4 letters (SE 0.96), CI: 3.5 - 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 GA (p = 0.024, Fisher exact test, odds ratio 9.4). A favorable safety profile was observed. CONCLUSIONS LIGHTSITE III provides a prospective, randomized controlled trial showing improved clinical and anatomical outcomes in intermediate dry AMD following PBM.en600 - Technology::610 - Medicine & healtharticle10.48350/1891273797295510.1097/IAE.0000000000003980