The purpose of this registry study is to collect real life data pertaining to the safety and clinical effectiveness of multi-wavelength photobiomodulation (PBM) as provided by the Valeda Light Delivery System in participants with dry age-related macular degeneration (AMD) in routine clinical practice. Data will be collected retrospectively and prospectively. PBM involves the use of visible light to near infrared light (NIR) (500-1000 nanometers) produced by a laser or a non-coherent light source applied to the surface of the body to activate mitochondrial respiratory chain components, stabilize metabolic function, and promote cellular proliferation. This registry study will be conducted in Europe, the US, and select other countries approved by their regulatory agency. This registry study was initiated as a combined retrospective and prospective data collection effort. After the acquisition of LumiThera by Alcon Research, LLC in September 2025, the study was amended to prospectively collect data from U.S. sites starting in July 2026.
In this multi-center registry study, each qualifying eye will or will have been treated with the Valeda Light Delivery System for a total of nine short, non-invasive treatments over a three-to-five-week period and retreated every four to six months for a total of up to six rounds of treatment, as determined by the investigator. Participants are considered to have completed the study if they complete at least one full treatment round with Optical Coherence Tomography (OCT) imaging collected post treatment. Participation may last up to 31 months, or as determined by the Investigator as the duration between treatment rounds and number of treatment rounds may vary by participant based on the progression of the disease as determined by the Investigator.
Study Type
OBSERVATIONAL
Enrollment
500
FDA-approved, multi-wavelength light delivery system for providing a pre-set treatment of pulsed light in 3 distinct wavelengths (PBM) to the participant's eye and retinal tissue through the open and closed eyelid. The Valeda Light Delivery System is a CE Marked Class IIa device in Europe (Certificate # CE 653115) and a Class 2 device in the United States (DEN230083).
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
NOT_YET_RECRUITINGCincinnati Eye Institute
Cincinnati, Ohio, United States
NOT_YET_RECRUITINGCarolina Eyecare Physicians
Charleston, South Carolina, United States
NOT_YET_RECRUITINGValley Retina Institute
McAllen, Texas, United States
RECRUITINGPacific Northwest Retina
Silverdale, Washington, United States
NOT_YET_RECRUITINGInstitutt for Oyehelse
Oslo, Norway
ACTIVE_NOT_RECRUITINGChange in Visual Acuity from Baseline at each Treatment Visit
Visual acuity will be assessed prior to any PBM treatment (baseline) and at each treatment visit after PBM was delivered.
Time frame: Baseline (Day 0) pre-treatment; up to Month 31/exit
Number of Adverse Events Associated with PBM Treatment
The number of adverse events associated with PBM treatment will be reported.
Time frame: Up to Month 31/exit
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