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Age-Related Macular Degeneration (ARMD) Clinical Trials

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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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).

Locations
United States
California
Retina Vitreous Associates Medical Group
NOT_YET_RECRUITING
Beverly Hills
Kentucky
Retina Associates of Kentucky
NOT_YET_RECRUITING
Lexington
New York
Ichan School of Medicine at Mount Sinai
NOT_YET_RECRUITING
New York
South Carolina
Carolina Eyecare Physicians
NOT_YET_RECRUITING
Charleston
Texas
Valley Retina Institute
RECRUITING
Mcallen
Washington
Pacific Northwest Retina
NOT_YET_RECRUITING
Silverdale
Other Locations
Norway
Institutt for Oyehelse
ACTIVE_NOT_RECRUITING
Oslo
Contact Information
Primary
Alcon Call Center
alcon.medinfo@alcon.com
1-888-451-3937
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2028-11
Participants
Target number of participants: 500
Treatments
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
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: LumiThera, Inc.

This content was sourced from clinicaltrials.gov

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