A DOUBLE-MASKED, RANDOMIZED, SHAM-CONTROLLED, SINGLE-CENTER STUDY WITH PHOTOBIOMODULATION FOR THE TREATMENT OF DRY...

Area of Science:

• Ophthalmology
• Biomedical Engineering

Background:

• Dry age-related macular degeneration (AMD) is a leading cause of vision loss in older adults.
• Current treatments for dry AMD are limited, highlighting the need for novel therapeutic approaches.

Purpose of the Study:

• To investigate the efficacy and safety of photobiomodulation (PBM) treatment using the Valeda Light Delivery System in patients with dry age-related macular degeneration (AMD).

Main Methods:

• A total of 30 subjects (46 eyes) received PBM treatment over one year, with two series of treatments administered three times per week for 3-4 weeks.
• Outcome measures included best-corrected visual acuity (BCVA), contrast sensitivity, microperimetry, central drusen volume and thickness, and quality of life assessments.

Main Results:

• PBM treatment resulted in a mean BCVA letter score gain of 4 letters post-treatment at months 1 and 7.
• Approximately 50% of PBM-treated subjects experienced a ≥5 letter improvement in BCVA, compared to 13.6% in the sham group.
• Significant improvements were observed in contrast sensitivity, central drusen volume and thickness, and quality of life (P < 0.05), with no device-related adverse events.

Conclusions:

• PBM treatment demonstrated statistically significant improvements in both clinical and anatomical outcomes for dry AMD.
• More pronounced benefits were noted in patients with earlier stages of dry AMD.
• Repeated PBM treatments are essential for sustaining therapeutic benefits, supporting PBM as a safe and effective option for dry AMD.