A Registry Study to Assess Photobiomodulation in Dry Age-Related Macular Degeneration (GLOBALIGHT)

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Visual Acuity from Baseline at each Treatment Visit — Baseline (Day 0) pre-treatment; up to Month 31/exit
  Visual acuity will be assessed prior to any PBM treatment (baseline) and at each treatment visit after PBM was delivered.
• Number of Adverse Events Associated with PBM Treatment — Up to Month 31/exit
  The number of adverse events associated with PBM treatment will be reported.

Trial sites (7)