Dry Age-related Macular DegenerationNCT06351605
A Registry Study to Assess Photobiomodulation in Dry Age-Related Macular Degeneration (GLOBALIGHT)
An observational study of Dry Age-related Macular Degeneration, run by LumiThera, Inc. at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dry Age-related Macular Degeneration
- What is being tested?
- Valeda® Light Delivery System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 Sep 2023to Nov 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
United States5 sites, 5 recruiting
- Not yet recruiting
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
- Not yet recruiting
Carolina Eyecare Physicians
Charleston, South Carolina, 29414
- Not yet recruiting
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
- Recruiting
Valley Retina Institute
McAllen, Texas, 78503
- Not yet recruiting
Pacific Northwest Retina
Silverdale, Washington, 98383
About this study
Official title: A Multi-Center Registry Study to Assess the Safety and Effectiveness of Photobiomodulation (PBM) in Participants With Dry Age-Related Macular Degeneration (AMD) (GLOBALIGHT)
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.
Read more
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.
Read the detailed description
In this multi-center registry study, each qualifying eye will or will have been treated with the Valeda Light Delivery System for a total of nine short, non-invasive treatments over a three-to-five-week period and retreated every four to six months for a total of up to six rounds of treatment, as determined by the investigator.
Participants are considered to have completed the study if they complete at least one full treatment round with Optical Coherence Tomography (OCT) imaging collected post treatment. Participation may last up to 31 months, or as determined by the Investigator as the duration between treatment rounds and number of treatment rounds may vary by participant based on the progression of the disease as determined by the Investigator.
- Conditions
- Dry Age-related Macular Degeneration
- Being tested
- Valeda® Light Delivery System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valeda® Light Delivery SystemDevice
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Valeda® Light Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to Month 31/exit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Sep 2023
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- LumiThera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Principal Clinical Trial Operations, Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351605
- Sponsor's protocol ID
- CSP006
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Registry Study to Assess the Safety and Effectiveness of Photobiomodulation (PBM) in Participants With Dry Age-Related Macular Degeneration (AMD) (GLOBALIGHT)
- ClinicalTrials.gov ID
- NCT06351605
- Acronym / sponsor ID
- CSP006
- Conditions
- Dry Age-related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- LumiThera, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this multi-center registry study, each qualifying eye will or will have been treated with the Valeda Light Delivery System for a total of nine short, non-invasive treatments over a three-to-five-week period and retreated every four to six months for a total of up to six rounds of treatment, as determined by the investigator.
Participants are considered to have completed the study if they complete at least one full treatment round with Optical Coherence Tomography (OCT) imaging collected post treatment. Participation may last up to 31 months, or as determined by the Investigator as the duration between treatment rounds and number of treatment rounds may vary by participant based on the progression of the disease as determined by the Investigator.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation (PBM) | – | Device: Valeda® Light Delivery SystemTwo 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valeda® Light Delivery SystemFDA-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). | Device | Photobiomodulation (PBM) |
Primary outcome
Change in Visual Acuity from Baseline at each Treatment Visit
Time frame: 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
Time frame: Up to Month 31/exit
The number of adverse events associated with PBM treatment will be reported.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sr. Principal Clinical Trial Operations, Surgical study director
Alcon Research, LLC
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Age-related Macular Degeneration, run by LumiThera, Inc. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alcon Call Center (1-888-451-3937, alcon.medinfo@alcon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Acuity from Baseline at each Treatment Visit (time frame: Baseline (Day 0) pre-treatment; up to Month 31/exit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.