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A Registry Study to Assess Photobiomodulation in Dry Age-Related Macular Degeneration (GLOBALIGHT)
Sponsor: LumiThera, Inc.
Summary
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.
Official title: A Multi-Center Registry Study to Assess the Safety and Effectiveness of Photobiomodulation (PBM) in Participants With Dry Age-Related Macular Degeneration (AMD) (GLOBALIGHT)
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2023-09-01
Completion Date
2028-11
Last Updated
2026-09-22
Healthy Volunteers
No
Conditions
Interventions
Valeda® Light Delivery System
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).
Locations (6)
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Carolina Eyecare Physicians
Charleston, South Carolina, United States
Valley Retina Institute
McAllen, Texas, United States
Pacific Northwest Retina
Silverdale, Washington, United States
Institutt for Oyehelse
Oslo, Norway