Evidence map›Paper›PMID 36588113›Full record

ArticleOphthalmology and therapy2023

LIGHTSITE II Randomized Multicenter Trial: Evaluation of Multiwavelength Photobiomodulation in Non-exudative Age-Related Macular Degeneration.

Ben Burton, Maurizio Battaglia Parodi, Ignasi Jürgens, Xavier Zanlonghi, Dan Hornan, Johann Roider, Katrin Lorenz, Marion R Munk, Cindy L Croissant, Stephanie E Tedford and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03878420 (A Double-Masked, Randomized, Sham-Controlled, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Photobiomodulation), which is not on this map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
11.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03878420 nacompletednot on this map

A Double-Masked, Randomized, Sham-Controlled, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Photobiomodulation (PBM) in Subjects With Dry Age-Related Macular Degeneration (AMD) (LIGHTSITE II)

TypeinterventionalSponsorLumiThera, Inc.Ran2019 to 2021Enrolled44ConditionsDry Age-related Macular DegenerationArmsValeda PBM treatment, Valeda Sham treatment
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 48 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Non neovascular Age - related macular degeneration - Review on clinical and imaging advances.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 7 countries.

Ben BurtonJames Paget University, Great Yarmouth, UK.
Maurizio Battaglia ParodiDepartment of Ophthalmology, Vita-Salute San Raffaele University, Istituto Scientifico Ospedale San Raffaele IRCSS, Milan, Italy.
Ignasi JürgensInstitut Català de Retina, Barcelona, Spain.
Xavier ZanlonghiInstitut Ophtalmologique de L'Ouest-Clinique Jules VERNE, Nantes, France.
Dan HornanPeterborough City Hospital, Peterborough, UK.
Johann RoiderKlinik Fur Ophthalmologie, Universitatsklinikum Schleswig-Holstein, Kiel, Germany.
Katrin LorenzUniversitätsmedizin Mainz-Augenklinik, Mainz, Germany.
Marion R MunkDepartment of Ophthalmology, Inselspital University Hospital Bern, Bern, Switzerland.
Cindy L CroissantLumiThera, Inc, Poulsbo, WA, USA.
Stephanie E TedfordLumiThera, Inc, Poulsbo, WA, USA. setedford@lumithera.com.ORCID http://orcid.org/0000-0001-7402-6789
Michael WalkerLumiThera, Inc, Poulsbo, WA, USA.
Rene RuckertLumiThera, Inc, Poulsbo, WA, USA.
Clark E TedfordLumiThera, Inc, Poulsbo, WA, USA.
Peninsula Cancer Center · USClinique Jules Verne · FRInstitut Català de Retina · ESJames Paget University Hospital · GBJohannes Gutenberg University Mainz · DEPeterborough City Hospital · GBUniversity Hospital of Bern · CHUniversity Hospital Schleswig-Holstein · DEVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPhotobiomodulation (PBM) represents a potential treatment for non-exudative age-related macular degeneration (AMD). PBM uses wavelengths of light to target components of the mitochondrial respiratory chain to improve cellular bioenergetic outputs. The aim of this study was to further investigate the effects of PBM on clinical, quality of life (QoL) and anatomical outcomes in subjects with intermediate stage non-exudative AMD.

methodsThe multicenter LIGHTSITE II study was a randomized clinical trial evaluating safety and efficacy of PBM in intermediate non-exudative AMD. The LumiThera Valeda® Light Delivery System delivered multiwavelength PBM (590, 660 and 850 nm) or sham treatment 3 × per week over 3-4 weeks (9 treatments per series) with repeated treatments at baseline (BL), 4 and 8 months. Subjects were enrolled with 20/32 to 20/100 best-corrected visual acuity (BCVA) and no central geographic atrophy (GA) within the central fovea (500 μm).

resultsLIGHTSITE II enrolled 44 non-exudative AMD subjects (53 eyes). PBM-treated eyes showed statistically significant improvement in BCVA at 9 months (n = 32 eyes, p = 0.02) with a 4-letter gain in the PBM-treated group versus a 0.5-letter gain in the sham-treated group (ns, p < 0.1) for patients that received all 27 PBM treatments (n = 29 eyes). Approximately 35.3% of PBM-treated eyes showed ≥ 5-letter improvement at 9 months. Macular drusen volume was not increased over time in the PBM-treated group but did show increases in the sham-treated group. While PBM and sham groups both showed GA lesion growth in the trial period, there was 20% less growth in the PBM group over 10 months, suggesting potential disease-modifying effects. No safety concerns or signs of phototoxicity were observed.

conclusionThese results confirm previous clinical testing of multiwavelength PBM and support treatment with Valeda as a novel therapy with a unique mechanism of action as a potential treatment for non-exudative AMD.

trial registrationClinicaltrial.Gov Registration Identifier: NCT03878420.

Indexed as

Age related macular degenerationMitochondriaMultiwavelengthOcular diseasePhotobiomodulationVision

Identifiers

PMID36588113
PMCPMC9805913
OpenAlexW4313382422

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.