Source: Arvos Journal
LIGHTSITE III 24-Month Analysis: Evaluation of Multiwavelength Photobiomodulation in Dry Age-Related Macular Degeneration Using the LumiThera Valeda Light Delivery System
Abstract
Purpose : Dry age-related macular degeneration (AMD) is a leading contributor to visual impairment across the globe. No current treatment exists to improve visual function or reduce disease progression outside of vitamin supplementation and lifestyle changes. The LIGHTSITE III study evaluated multiwavelength photobiomodulation (PBM) treatment using the LumiThera Valeda® Light Delivery System in dry AMD.
Methods : LIGHTSITE III (NCT04065490) was a prospective, double-masked, randomized, sham-controlled, parallel group, multi-center study to assess the safety and efficacy of PBM in dry AMD. PBM therapy 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 multi-wavelength PBM (590, 660 and 850 nm) or active Sham (3x per week/3-5 weeks) treatment delivered every 4 months over a 24-month period using the LumiThera Valeda® Light Delivery System. Subjects were assessed for clinical and safety outcomes. Independent OCT, FAF and color fundus imaging outcomes at selected timepoints are analyzed by a masked imaging reading center. Data from the 24-month analysis are presented.
Results : 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) and a gain of 5.4 letters following PBM treatment. A total of 55% of PBM-treated eyes showed ≥ 5 letter gain (mean 9.7 ± 3.7), 26.4% showed ≥10 letter gain (mean 12.8 ± 2.7) and 5.5% showed ≥ 15 letter gain. A favorable safety profile was observed. The treatment showed a positive benefit-risk profile with high subject compliance. Clinical and anatomical outcome data from the 24-month analysis are presented.
Conclusions : LIGHTSITE III provides the largest randomized controlled trial in dry AMD showing improved clinical and anatomical outcomes following PBM treatment. PBM therapy may offer a new treatment strategy with a unique mechanism and modality for patients with dry AMD.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.
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