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

NCT06351605 | Recruiting FDA Device

• 1 other identifier: CSP006
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

Dry Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Change 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.

  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.

  Up to Month 31/exit

Study Arms (1)

Photobiomodulation (PBM)

Two alternating and sequential treatments with the Valeda Light Delivery System of 590 nm and 850 nm for 35 seconds, or a total of 70 seconds, followed by 660 nm for 90 seconds, or a total of 180 seconds

Device: Valeda® Light Delivery System

Interventions

Valeda® Light Delivery System DEVICE

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).

Photobiomodulation (PBM)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patient population for this study will consist of a target of at least 25 male and female participants per site of any ethnic background and with a diagnosis of dry AMD by the Investigator or confirmed by the Investigator. The participant must meet all the inclusion criteria, have none of the exclusion criteria, and give their written Informed Consent to participate in this clinical study. Only if the participant is interested in participating, s/he would be given the option to sign the study consent and start the study procedures, or if retrospectively signing the informed consent form, have their data used in the study.

You may qualify if:

• Diagnosis or confirmation of diagnosis of dry AMD disease by Investigator;
• Able to communicate well with the Investigator and able to understand and comply with the requirements of the study;
• Informed of the nature of this study and has provided written, informed consent; (participants enrolled retrospectively will need to be contacted and sign an informed consent form prior to their data being used).

You may not qualify if:

• US Sites Only: Center-involving geographic atrophy;
• Neovascular maculopathy;
• Use of any photosensitizing agent (e.g. topicals, injectables) activated by the Valeda Light Deliver System within 30 days prior to treatment without consulting participant's physician;
• Known photosensitivity to yellow light, red light, or near infrared radiation (NIR), or has a history of light activated central nervous system disorders (e.g. epilepsy, migraine);
• In the opinion of the Investigator, is unlikely to comply with the study protocol or has a history or current evidence of any condition that, in the opinion of the investigator, might interfere with the participant's involvement in the trial, or is not in the best interest of the participant.

Sponsors & Collaborators

• LumiThera, Inc.: lead

Study Sites (6)

Retina Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

NOT YET RECRUITING

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

NOT YET RECRUITING

Carolina Eyecare Physicians

Charleston, South Carolina, 29414, United States

NOT YET RECRUITING

Valley Retina Institute

McAllen, Texas, 78503, United States

RECRUITING

Pacific Northwest Retina

Silverdale, Washington, 98383, United States

NOT YET RECRUITING

Institutt for Oyehelse

Oslo, 0366, Norway

ACTIVE NOT RECRUITING

Study Officials

• Sr. Principal Clinical Trial Operations, Surgical

  Alcon Research, LLC

  STUDY DIRECTOR

Central Study Contacts

Alcon Call Center

CONTACT

1-888-451-3937; alcon.medinfo@alcon.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); NO (1)