Vision improvements sustained with photobiomodulation at 24 months in dry AMD trial
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Key takeaways:
- Photobiomodulation with the Valeda light delivery system delivered sustained improvements to best corrected visual acuity in patients with dry age-related macular degeneration at 24 months.
- Fewer eyes treated with photobiomodulation progressed to new geographic atrophy.
Photobiomodulation delivered with the Valeda light delivery system demonstrated sustained vision improvements at 24 months in patients with dry age-related macular degeneration, according to a press release from LumiThera.
The LIGHTSITE III clinical trial investigated the treatment in 100 patients with early to intermediate dry AMD at 10 U.S. retinal centers, with a primary efficacy endpoint of best corrected visual acuity. Eighty percent of patients completed the trial, and there were minimal safety risks and high patient compliance at the 24-month mark.
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Ninety-one eyes were randomly assigned to the photobiomodulation (PBM) treatment group and 54 eyes to the sham treatment group. At 24 months, the trial demonstrated a sustained mean increase in ETDRS letter score of more than five letters, reported at both the initial 13-month and 21-month timepoints in the PBM cohort (P < .0001).
BCVA improvement at 24 months from baseline was significantly greater in the PBM arm than in the sham arm (5.9 vs 1.0 letters; P = .0015), and approximately 58% of the PBM-treated eyes experienced a gain of more than five letters, with a mean letter gain of 8.5 ± 0.5.
In addition, a retinal morphology analysis using OCT showed that fewer eyes treated with PBM progressed to new geographic atrophy (GA), according to Glenn J. Jaffe, MD, of Duke Reading Center at Duke University.
“The 24-month OCT data indicated that five of 88 eyes (5.7%) in the PBM group had progressed to new GA, whereas 11 of 51 eyes (21.6%) in the sham arm developed new GA,” he said in the release. “PBM treatment showed a statistically significant (P = .003) slowing of disease progression in patients with early to intermediate dry AMD.”
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