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. 2021 May 6;2021(5):CD013029. doi: 10.1002/14651858.CD013029.pub2

NCT04065490 (LIGHTSITE III).

Study name Study to Assess the Safety and Efficacy of Photobiomodulation (PBM) in Subjects With Dry Age‐Related Macular Degeneration (AMD) (LIGHTSITE III)
Methods Double‐masked, randomised, sham‐controlled, parallel group, multi‐centre
Participants Non‐exudative age‐related macular degeneration
Interventions Experimental: the Valeda™ Light Delivery System
Comparator: the sham mode of the Valeda™ Light Delivery System
Outcomes Primary:
  • best‐corrected visual acuity at 21 months


Secondary:
  • contrast sensitivity

  • central drusen volume

  • central drusen thickness


Other:
  • visual function questionnaire

  • reading speed

  • geographic atrophy

  • low luminance ‐ best‐corrected visual acuity

Starting date September 2019
Contact information Clark Tedford ctedford@lumithera.com
Cindy Croissant ccroissant@lumithera.com
Notes