June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
LIGHTSITE III (Interim Analysis): Evaluation of Multiwavelength Photobiomodulation in Dry Age-Related Macular Degeneration Using the LumiThera Valeda Light Delivery System
Author Affiliations & Notes
  • Marion Ronit Munk
    Inselspital, University Hospital Bern, Switzerland
  • Victor H. Gonzalez
    Valley Retina Institute, Texas, United States
  • David S Boyer
    Retina Vitreous Associates Medical Group, California, United States
  • Diana V Do
    Byers Eye Institute, California, United States
  • Samantha Xavier
    Florida Eye Clinic, Florida, United States
  • Allen Hu
    Cumberland Valley Retina Consultants, Maryland, United States
  • Richard B Rosen
    New York Ear and Eye Infirmary of Mount Sinai, New York, United States
  • Eleonora Lad
    Duke Reading Center, Duke University School of Medicine, North Carolina, United States
  • Todd Schneiderman
    Retina Center NorthWest, Washington, United States
  • Allen C Ho
    Mid Atlantic Retina, New Jersey, United States
  • Glenn Jaffe
    Duke Reading Center, Duke University School of Medicine, North Carolina, United States
  • David Warrow
    Cumberland Valley Retina Consultants, Pennsylvania, United States
  • Stephanie Tedford
    LumiThera, Inc, Washington, United States
  • Cindy Croissant
    LumiThera, Inc, Washington, United States
  • Rene Ruckert
    Eyegnos Consulting, Switzerland
  • clark tedford
    LumiThera, Inc, Washington, United States
  • Footnotes
    Commercial Relationships   Marion Munk Lumithera, Code C (Consultant/Contractor), Zeiss, Code C (Consultant/Contractor), Bayer, Code C (Consultant/Contractor), Novartis, Code C (Consultant/Contractor), Roche, Code C (Consultant/Contractor), Gensight, Code C (Consultant/Contractor), Occuterra, Code C (Consultant/Contractor), Isarna, Code C (Consultant/Contractor); Victor Gonzalez Lumithera, Code C (Consultant/Contractor); David Boyer Lumithera, Code C (Consultant/Contractor); Diana Do Lumithera, Code C (Consultant/Contractor); Samantha Xavier Lumithera, Code C (Consultant/Contractor); Allen Hu Lumithera, Code C (Consultant/Contractor); Richard Rosen lumithera, Code C (Consultant/Contractor); Eleonora Lad lumithera, Code C (Consultant/Contractor); Todd Schneiderman lumithera, Code C (Consultant/Contractor); Allen Ho lumithera, Code C (Consultant/Contractor); Glenn Jaffe lumithera, Code C (Consultant/Contractor); David Warrow LumiThera, Inc, Code C (Consultant/Contractor); Stephanie Tedford Lumithera Inc, Code E (Employment); Cindy Croissant Lumithera Inc, Code E (Employment); Rene Ruckert Lumithera Inc, Code C (Consultant/Contractor); clark tedford Lumithera Inc, Code E (Employment)
  • Footnotes
    Support   NIH grant 3R43EY025508-03
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 379 – F0210. doi:
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      Marion Ronit Munk, Victor H. Gonzalez, David S Boyer, Diana V Do, Samantha Xavier, Allen Hu, Richard B Rosen, Eleonora Lad, Todd Schneiderman, Allen C Ho, Glenn Jaffe, David Warrow, Stephanie Tedford, Cindy Croissant, Rene Ruckert, clark tedford; LIGHTSITE III (Interim Analysis): Evaluation of Multiwavelength Photobiomodulation in Dry Age-Related Macular Degeneration Using the LumiThera Valeda Light Delivery System. Invest. Ophthalmol. Vis. Sci. 2022;63(7):379 – F0210.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose : Dry age-related macular degeneration (AMD) is a leading contributor to visual impairment across the globe. No current treatment exists to improve visual function or reduce disease progression outside of vitamin supplementation and lifestyle changes. LIGHTSITE III is evaluating multiwavelength photobiomodulation (PBM) therapy using the LumiThera Valeda® Light Delivery System in dry AMD

Methods : LIGHTSITE III (NCT04065490) is a prospective, double-masked, randomized, sham-controlled, parallel group, multi-center study to assess the safety and efficacy of PBM in dry AMD. Target enrollment was approximately 96 subjects (144 eyes). Subjects are treated with six series of PBM/Sham treatments (3x per week for 3 weeks) delivered over a 24-month period with a 13-month efficacy analysis of data. PBM therapy consists of low-level light exposure to selected tissues resulting in positive effects on mitochondrial output and improvement in cellular activity. Valeda is used to deliver multiwavelength PBM treatment using 590, 660 and 850 nm of light. Subjects are assessed for clinical and safety outcomes (i.e., best-corrected visual acuity (BCVA), low-luminance BCVA, contrast sensitivity, reading speed, color vision, VFQ-25 and perimetry). Independent OCT, FAF and color fundus imaging outcomes at selected timepoints are analyzed by a masked imaging reading center

Results : A total of 148 eyes from 100 subjects with dry AMD have been enrolled and randomized in a 2:1 design (PBM:Sham). The majority of subjects are female (68%) and Caucasian (99%). The average age at enrollment was 75 years and mean time since dry AMD diagnosis is 4.9 years. COVID-19 interference has been minimal and not significantly impacted subject enrollment or retention. Clinical and anatomical outcome data from the interim analysis conducted at Month 13 is presented. Results from the 21-month time point are expected at end of 2022

Conclusions : LIGHTSITE III provides the largest, randomized controlled trial evaluating the effects of PBM in dry AMD subjects. PBM therapy may offer a new treatment strategy with a unique mechanism and modality for patients with dry AMD

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.


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