NCT06351605 A Registry Study to Assess Photobiomodulation in Dry Age-Related Macular Degeneration (GLOBALIGHT)
| NCT ID | NCT06351605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | LumiThera, Inc. |
| Condition | Dry Age-related Macular Degeneration |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-09-01 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Diagnosis or confirmation of diagnosis of dry AMD disease by Investigator; 2. Able to communicate well with the Investigator and able to understand and comply with the requirements of the study; 3. 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). Exclusion Criteria: * 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.
Contact & Investigator
Sr. Principal Clinical Trial Operations, Surgical
STUDY DIRECTOR
Alcon Research, LLC
Frequently Asked Questions
Who can join the NCT06351605 clinical trial?
This trial is open to participants of all sexes, studying Dry Age-related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06351605 currently recruiting?
Yes, NCT06351605 is actively recruiting participants. Contact the research team at alcon.medinfo@alcon.com for enrollment information.
Where is the NCT06351605 trial being conducted?
This trial is being conducted at Beverly Hills, United States, Cincinnati, United States, Charleston, United States, McAllen, United States and 2 additional locations.
Who is sponsoring the NCT06351605 clinical trial?
NCT06351605 is sponsored by LumiThera, Inc.. The principal investigator is Sr. Principal Clinical Trial Operations, Surgical at Alcon Research, LLC. The trial plans to enroll 500 participants.