RecruitingNCT06351605

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

A Multi-Center Registry Study to Assess the Safety and Effectiveness of Photobiomodulation (PBM) in Participants With Dry Age-Related Macular Degeneration (AMD) (GLOBALIGHT)

Sponsor

LumiThera, Inc.

Enrollment

500 participants

Start Date

Sep 1, 2023

Study Type

OBSERVATIONAL

Conditions

Dry Age-Related Macular Degeneration

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

Plain Language Summary

Simplified for easier understanding

The EUROLIGHT registry study collects real-world data on the safety and effectiveness of photobiomodulation (PBM) therapy — a non-invasive light-based treatment using the Valeda device — in patients with dry age-related macular degeneration (AMD), a leading cause of vision loss in older adults. Participants receive up to nine short treatment sessions over 3–4 weeks, with optional additional rounds every 4–6 months, while standard vision tests and retinal imaging are collected before and after treatment. Adults with a confirmed diagnosis of dry AMD who can cooperate with study procedures and provide informed consent are eligible; patients with a history of wet (exudative) AMD, diabetic macular edema, or photosensitivity disorders are excluded. Participation combines standard clinical care with registry data collection at participating European centers. This summary was prepared as patient-facing educational content using AI assistance.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEValeda® 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).