gms | German Medical Science

Objective: Dry age-related macular degeneration (AMD) is a leading cause of visual impairment and blindess. The LIGHTSITE III study evaluated multiwavelength photobiomodulation (PBM) treatment using the LumiThera Valeda^® Light Delivery System in subjects with dry AMD.

Method: The LIGHTSITE III multi-center trial was a prospective, double masked, randomized study conducted at 10 clinical sites across the United States. PBM consists of low-level light exposure to selected tissues resulting in positive effects on mitochondrial output and improvement in cellular activity. Subjects were treated with six series of multiwavelength PBM (590, 660 and 850 nm) or Sham (3x per week/3–5 weeks) treatment delivered every 4 months over a 24-month period. Subjects were assessed for clinical and safety outcomes and independent OCT, FAF and color fundus outcomes at selected timepoints. Data from the 24-month analysis are presented.

Result: A total of 100 subjects (148 eyes) with dry AMD were randomized. The majority of subjects were female (n=68; 68.0%) and Caucasian (n=99, 99.0%), with a mean age of 75.4 years (SD 7.1) and a mean time since diagnosis of 4.9 yrs. LIGHTSITE III met the predetermined primary efficacy BCVA endpoint at 13 Months with a statistically significant difference between PBM and Sham (p=0.02). An improved BCVA with a mean gain of 5.4 letters at Month 13 (p=0.02) and sustained improvement of 5.9 letters at Month 24 was observed (p=0.0015). A total of 58.2% of PBM-treated eyes showed ≥ 5 letter gain (mean 8.5 ± 2.1), 18.7% showed ≥10 letter gain (mean 13.4 ± 2.5) and 5.5% showed ≥15 letter gain (mean 16.6 ± 1.8) at 24 months. Occurrence of new geographic atrophy (GA) was observed in 12/50 (24.0%) of Sham eyes and 6 of 87 (6.8%) of PBM eyes. The progression to new GA in eyes with intermediate dry AMD was significantly higher in the Sham group than in the PBM group (p=0.007, Fisher exact test, odds ratio 4.2). PBM treatment with Valeda shows an excellent safety profile with high compliance and no signs of phototoxicity.

Conclusion: LIGHTSITE III provides randomized controlled trial data in dry AMD showing sustained BCVA clinical improvement and positive impact on anatomical outcomes including a reduced progression to new GA following PBM treatment. A favorable safety profile was observed. The treatment showed a positive benefit-risk profile with high subject compliance. Valeda multiwavelength PBM therapy may offer a non-invasive treatment strategy with a unique mechanism and modality for patients with dry AMD.