LONG-TERM EFFICACY AND SAFETY OF PHOTOBIOMODULATION IN DRY AGE-RELATED MACULAR DEGENERATION (LIGHTSITE III: 24-MONTH ANALYSIS)
Jaffe GJ, Boyer D, Hu A, Warrow D, Xavier S, Gonzalez V, Lad E, Rosen RB, Do DV, Schneiderman T, Ho AC, Munk MR, Tedford SE, Croissant CL, Rückert R, Lavin PT, Tedford CE
Retina (Philadelphia, Pa.) · 7 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- NEI NIH HHS
- Gobierno
- National Eye Institute
Según 2 financiadores declarados.
Publicación
- Publicado
- 2026-03-06 · Retina · vol. 46 · número 5 · págs. 783–795
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 9 citas · más que el 100% de estudios similares · 69.0× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 31 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY-NC-ND
- Áreas de investigación
- Retinal Diseases and Treatments · Laser Applications in Dentistry and Medicine · Ocular and Laser Science Research
- Palabras clave
- low-level laser therapy, dry age-related macular degeneration, geographic atrophy, visual acuity, disease progression, phototoxicity, quality of life, long-term safety
- MeSH
- humans, tomography, optical coherence, fluorescein angiography, treatment outcome, follow-up studies, prospective studies, double-blind method, visual acuity, time factors, aged, aged, 80 and over, female, male, geographic atrophy, low-level light therapy, red light
17 autores
- Glenn J. Jaffe🇺🇸Duke University
- David S. Boyer🇺🇸Retina Vitreous Associates Medical Group
- Allen Y. H. Hu
- David J. Warrow
- Samantha Xavier
- Victor Gonzalez🇺🇸Valley Retina Institute
- Eleonora Maries Lad🇺🇸Duke University; Duke Medical Center
- Richard B. Rosen🇺🇸New York Eye and Ear Infirmary
- Diana V. Do🇺🇸Stanford University
- Todd E. Schneiderman
- Allen C. Ho🇺🇸Mid Atlantic Retina; Wills Eye Hospital
- Marion Ronit Munk🇺🇸🇨🇭Northwestern University; University of Bern; University Hospital of Bern
- Stephanie E. Tedford
- Cindy L. Croissant
- René Rückert
- Philip T. Lavin
- Clark E. Tedford
Resumen
El texto original del estudio, en el idioma en que se publicó.
Purpose
To evaluate the safety and efficacy of multiwavelength photobiomodulation (PBM) in nonexudative (dry) age-related macular degeneration (AMD).
Methods
LIGHTSITE III used a double-masked, randomized, sham-controlled, parallel-group, prospective study design. Subjects were enrolled with a diagnosis of dry AMD and treated with multiwavelength PBM (Valeda Light Delivery System; 590, 660, and 850 nm) or sham treatment. A treatment series included 9 PBM or sham treatments delivered 3x/week over 3 to 5 weeks every 4 months (M) for 24M.
Results
A total of 148 eyes (100 subjects) with dry AMD were randomized into the study. LIGHTSITE III met the prespecified primary BCVA efficacy end point at M21 with a significant difference between treatment groups ( P = 0.0036) and a +6.2 letter gain after PBM. At M21, 61.5% of PBM-treated eyes showed ≥5, 23.1% showed ≥10, and 4.4% showed ≥15 letter gains. A favorable safety profile was observed with no signs of phototoxicity. Disease progression to Geographic Atrophy (GA) showed a significant decrease in incidence (Sham, 24.0% vs. PBM, 6.8%; P = 0.007) after PBM treatment at M24. Significant benefit in vision QoL was observed.
Conclusion
Multiwavelength PBM represents an interventional therapy that restores visual function and has potential disease-modifying effects in intermediate dry AMD.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC-ND).
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