A Double-Masked, Randomized, Sham-Controlled, Single-Center Study With Photobiomodulation for the Treatment of Dry Age-Related Macular Degeneration

Abstract

Purpose: The LIGHTSITE I study investigated the efficacy and safety of photobiomodulation (PBM) treatment in subjects with dry age-related macular degeneration. Methods: Thirty subjects (46 eyes) were treated with the Valeda Light Delivery System, wherein subjects underwent two series of treatments (3• per week for 3-4 weeks) over 1 year. Outcome measures included best-corrected visual acuity, contrast sensitivity, microperimetry, central drusen volume and drusen thickness, and quality of life assessments. Results: Photobiomodulation-treated subjects showed a best-corrected visual acuity mean letter score gain of 4 letters immediately after each treatment series at Month 1 (M1) and Month 7 (M7). Approximately 50% of PBM-treated subjects showed improvement of $5 letters versus 13.6% in sham-treated subjects at M1. High responding subjects ($5letter improvement) in the PBM-treated group showed a gain of 8 letters after initial treatment (P , 0.01) and exhibited earlier stages of age-related macular degeneration disease. Statistically significant improvements in contrast sensitivity, central drusen volume, central drusen thickness, and quality of life were observed (P , 0.05). No device-related adverse events were reported. Conclusion: Photobiomodulation treatment statistically improved clinical and anatomical outcomes with more robust benefits observed in subjects with earlier stages of dry agerelated macular degeneration. Repeated PBM treatments are necessary to maintain benefits. These pilot findings support previous reports and suggest the utility of PBM as a safe and effective therapy in subjects with dry age-related macular degeneration.

Comparison of Drusen Volume Assessed by Two Different OCT Devices

“…The mean 1 and 3 mm ETDRS circle manually corrected drusen volume determined by Heidelberg SD-OCT was significantly different from the Zeiss SS-OCT assessed and manually corrected 1 and 3 mm ETDRS circle drusen volume with a moderate correlation (mean difference: 0.1231 ± 0.0371 mm 3 , p-value ≤ 0.001, corr. p ≤ 0.001, correlation of r = 0.681) ( Figure 4A).…”

“…In the Zeiss SS-OCT there was no significant difference between manufacturer automated assessment? mean 1 and 3 mm ETDRS circle drusen volume and manually corrected mean 1 and 3 mm ETDRS circle drusen volume (mean difference: 0.0001 ± 0.0003 mm 3 , p = 0.262, corr. p = 0.524, r = 1.0).…”

“…There was a significant difference between the 1 and 3 mm ETDRS circle drusen volumes of the Heidelberg SD-OCT images using the customized discovery software versus the manually corrected manufacturer software (mean difference: 0.0547 ± 0.0744 mm 3 , p < 0.001, corr. p < 0.001, correlation of r = 0.798).…”

Novel Programmed Cell Death as Therapeutic Targets in Age-Related Macular Degeneration?

“…The antioxidants reduce RPE damage by limiting the generation of free radicals, protecting photoreceptors and acting as retinal tissue nutrients [ 66 ]. In addition, recent single-center studies showed that photobiomodulation, a recently proposed light therapy, improved symptoms and reversed pathological changes (drusen formation) without causing harmful effects [ 67 , 68 ], suggesting a novel strategy for the earlier stage of AMD.…”

Photobiomodulation of the Visual System and Human Health

“…Markowitz et al recently used PBM therapy to treat patients with the dry (more common and difficult to treat) form of macular degeneration. They found that application of multiple wavelengths (590, 660, 850 nm) over a year, compared to a sham treatment, significantly reduced the volume of central drusen and improved visual function [154].…”