LIGHTSITE III: 13-Month Efficacy and Safety Evaluation of Multiwavelength Photobiomodulation in Nonexudative (Dry) Age-Related Macular Degeneration Using the Lumithera Valeda Light Delivery System.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 37972955 · doi:10.1097/IAE.0000000000003980
What was done
The LIGHTSITE III randomized controlled trial evaluated the efficacy and safety of multiwavelength photobiomodulation (PBM at 590, 660, and 850 nm) using the LumiThera Valeda Light Delivery System in patients with nonexudative (dry) age-related macular degeneration (AMD). Participants received PBM or sham treatments in cycles of 9 sessions over 3 to 5 weeks, repeated every 4 months over 24 months. Outcomes were assessed at a pre-specified 13-month interim analysis.
What was found
Among 100 randomized subjects (148 eyes), 91 eyes received PBM and 54 eyes received sham. The trial met its primary endpoint of best-corrected visual acuity (BCVA): the between-group difference was 2.4 letters (SE 1.15, 95% CI -4.7 to -0.1, P = 0.02). Within groups, BCVA improved by 5.4 letters in the PBM arm (SE 0.96, 95% CI 3.5 to 7.3, P < 0.0001) and by 3.0 letters in the sham arm (SE 1.13, 95% CI 0.7 to 5.2, P < 0.0001). The PBM group also showed a significant reduction in new-onset geographic atrophy compared to sham (odds ratio 9.4, P = 0.024, Fisher exact test). A favorable safety profile was observed.
Why it matters
This trial provides randomized clinical evidence that non-invasive multiwavelength photobiomodulation may improve visual acuity and slow anatomical progression to geographic atrophy in dry AMD, a condition with limited therapeutic options.
Limits
The sample size is relatively small (100 subjects), and the report reflects an interim 13-month analysis rather than the full 24-month study duration. The sham group exhibited an unexpected visual gain of 3.0 letters, reducing the net treatment effect size to 2.4 letters. The abstract does not provide specific adverse event breakdowns, drop-out rates, or baseline disease severity details.
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