LIGHTSITE II Randomized Multicenter Trial: Evaluation of Multiwavelength Photobiomodulation in Non-exudative Age-Related Macular Degeneration.
Level 2 - randomized trial
Individual randomized sham-controlled clinical trial.
PubMed 36588113 · doi:10.1007/s40123-022-00640-6
What was done
The multicenter LIGHTSITE II trial evaluated the safety and efficacy of multiwavelength photobiomodulation (PBM; 590, 660, and 850 nm via the Valeda Light Delivery System) versus sham in 44 subjects (53 eyes) with intermediate non-exudative age-related macular degeneration (AMD). Participants had baseline best-corrected visual acuity (BCVA) of 20/32 to 20/100 and no central geographic atrophy (GA) within the central fovea (500 μm). Treatment was administered 3 times per week across 3–4 weeks (9 sessions per series) repeated at baseline, 4 months, and 8 months (up to 27 total sessions). Clinical, anatomical, and safety outcomes were evaluated over 9 to 10 months.
What was found
At 9 months, PBM-treated eyes achieved a statistically significant improvement in BCVA (n = 32 eyes, p = 0.02). Patients receiving all 27 PBM sessions (n = 29 eyes) gained 4 letters versus a 0.5-letter gain in the sham arm (p < 0.1). Approximately 35.3% of PBM-treated eyes gained ≥5 letters at 9 months. Macular drusen volume increased in the sham group over time but remained stable in the PBM group. Both groups exhibited GA lesion growth over 10 months, but growth was 20% lower in the PBM group. No phototoxicity or safety concerns were identified.
Why it matters
This study provides randomized sham-controlled clinical evidence that non-invasive multiwavelength photobiomodulation can improve visual acuity and may slow structural progression in intermediate dry AMD, a stage with few disease-modifying treatment options.
Limits
The study is limited by a small sample size (44 participants, 53 eyes) and a relatively short follow-up duration (9–10 months) for a chronic progressive disease. The abstract does not provide exact numerical values, standard deviations, or p-values for the drusen volume and GA growth differences, nor does it detail quality of life outcomes despite listing them as study objectives.
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