Improvement of Visual Function following Multi-wavelength Photobiomodulation with the Valeda Light Delivery System on Electroretinography (ERG) and Best Corrected Visual Acuity (BCVA) in Dry Age-related Macular Degeneration in the ELECTROLIGHT Study (Interim Analysis)

Abstract

Purpose : Electroretinography is a quantitative and functional indicator of visual function and is an important tool for the diagnosis and management of retinal function in ocular disease. Dry age-related macular degeneration (AMD) demonstrates underlying mitochondrial dysfunction. The Valeda multi-wavelength photobiomodulation (PBM) device, and the Diopsys NOVA ERG device were used to investigate the effects on multiple parameters of visual function in the ELECTROLIGHT dry AMD study.

Methods : A total of 23 eyes from 15 subjects with intermediate Dry AMD were enrolled into the prospective clinical study and treated with one series of PBM treatment using the Valeda (3x per week for 3 weeks). PBM therapy consists of low-level light exposure to selected tissues resulting in positive effects on mitochondrial Cytochrome C Oxidase output and improvement in metabolic activity. Subjects were assessed for clinical and safety outcomes (i.e., visual acuity, contrast sensitivity, color vision, amsler grid test, perimetry, and ERG). Independent OCT outcomes at 3- and 6-months post-treatment were analyzed by a masked imaging center. An interim analysis was performed following the month 1 study visit.

Results : Subjects showed approximately 12.6 ± 1.25 letter improvement in BCVA at Month 1 compared to BL scores. Mars Contrast Sensitivity (CS) also showed improvement from BL to 1 month at 40 cm (0.165 log + 0.25), 80 cm (0.134 log +0.20) and 120 cm (0.22 log + 0.37). A positive correlation between multiluminance ERG and BCVA was seen and strong positive correlations between multiluminance ERG and fixed luminance (R = 0.852) and Chromatic ERG outcomes. Reductions in drusen were seen in select patients. Multiluminance ERG Magnitude AUC improved by 14.4% from baseline to the fourth test after completion of the 1-month treatment, and this difference was determined to be significant (p = 0.001).

Conclusions : Valeda provided statistically significant improvements in BCVA, CS and multiluminance ERG function from baseline at the 1-month time point following 9 PBM treatments. PBM therapy represents a novel approach to treat patients with dry AMD. Diopsys multiluminance ERG may be used as an early and sensitive measure of visual dysfunction in dry AMD patients.

This is a 2021 ARVO Annual Meeting abstract.