Medical device company LumiThera this week announced the final results of the LIGHTSITE II clinical trial in patients with dry age-related macular degeneration. The prospective, double-masked, randomized, multicenter, prospective study was conducted at eight leading retina centers in Europe, including ICR.
The study aimed to test the effectiveness of photobiomodulation (PBM) treatment with three sessions every four months. It enrolled 44 individuals, with a mean age of 74 years and a mean duration of dry or atrophic AMD of 3.7 years from diagnosis. In total, 32 eyes were included in the group receiving PBM treatment and 19 eyes in the group receiving sham placebo treatment, all with at least one post-treatment visit.
The results showed a statistically significant improvement in the primary endpoint of corrected visual acuity (CVAcc) at nine months from baseline in PBM-treated patients. Also, no safety issues were identified after three rounds of PBM treatment administered at four-month intervals.
In a separate analysis, participants who completed all 27 PBM treatment visits planned according to the protocol were evaluated (not all patients were able to attend all visits due to the COVID-19 pandemic). A significant improvement in corrected visual acuity (CVAcc) at nine months from baseline was observed in PBM-treated participants. Thus, the average improvement in vision for the PBM group over the placebo-treated group at nine months was estimated to be approximately 4 letters versus a gain of 0.5 letters in the placebo-treated group.
Conclusions of the LIGHTSITE II study
The results show a steady improvement over time in corrected visual acuity measurements by administering PBM treatment at shorter intervals compared to the results of the LIGHTSITE I study, where some remission was observed between treatments when treatments were administered every six months. Thus, treatment intervals every four months allow benefits to be maintained more consistently.
Participation of the ICR Retina team in the study
Dr. Jürgens, ICR’s medical director, was one of the retina specialists who participated in the LumiThera study. As he explains, “The data showed that 35% of PBM-treated participants who completed all visits had an improvement of 5 more letters on the standard visual chart, which is more than double the percentage of participants in the placebo-treated group. These improvements in vision in subjects with atrophic AMD using Valeda treatments may have a positive impact on their quality of life.”
Thus, these data suggest that Valeda light delivery system may be a safe, noninvasive treatment opportunity for patients with atrophic AMD currently with few treatment options. However, due to the limited size of the study, all potential benefits will need to be further confirmed by larger studies.