An observational study in Dry Age-related Macular Degeneration, sponsored by LumiThera, Inc.. Recruiting at 6 sites in 2 countries. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by LumiThera, Inc. · Observational
Among 645 studies in Macular Degeneration with a site in United States — 85 open to participants now, 128 under way, 24 of them phase 3. Macular Degeneration · United States.
Among the 645 studies in Macular Degeneration with a site in United States, this one is the 32nd largest by planned enrollment of the 146 observational ones that give a count, is one of 24 that started in 2023, is one of 146 observational ones, reaches primary completion later than 95 of the 124 other live ones, and was the 569th registered.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
Browse Macular Degeneration studies →85 of the 645 studies in Macular Degeneration with a site in United States are open now. Recruiting first, the newest first:
Genentech, Inc. · Sites in United States
Ages 50+
Biojiva LLC · Sites in United States, Australia
Ages 55+
Sitala Bio LTD · Sites in United States, Argentina, Australia and 4 more countries
Ages 60+
Scott Raymond · Sites in United States
Ages 50–80
Astellas Institute for Regenerative Medicine · Sites in United States
Ages 6+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 166 Macular Degeneration studies recruiting now, 117 (70%) set no upper age limit and 5 (3%) stop at 75 or younger; 19 take children under 18; 35 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
645 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 152 · Phase 2 216 · Phase 3 103 · Phase 4 27
First in 1992; this study’s year is marked. 24 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 500 is above the median of 110 across 409 observational studies indexed under Macular Degeneration.
Median enrollment 55 across the 491 interventional studies, 100 across the 146 observational. Of the 464 that completed or were terminated, 183 (39%) have results posted.
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375 of 645 have an industry lead sponsor. The 10 most frequent:
LumiThera, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
LumiThera, Inc. has 6 studies filed under Macular Degeneration — fewer than ten, so there is no comparison to draw.
37 of the studies in Macular Degeneration with a site in United States that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04704921Phase 3AbbViePivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD | 2026-12 |
| NCT06495918Phase 3Ocular Therapeutix, Inc.Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration | 2027-01-08 |
| NCT06864988Phase 34D Molecular Therapeutics4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration | 2027-06 |
| NCT05904028Phase 3Jaeb Center for Health ResearchHome OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD | 2027-07-30 |
| NCT07614776Phase 3AmgenA Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration | 2027-07-31 |
Add all 37 to your calendar (.ics) → With an account.
Among the 645 studies in Macular Degeneration with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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).
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.
Time frame: 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.
Time frame: Up to Month 31/exit
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Nov 2028, 62 months after the start.
Of 56 industry-sponsored observational studies under Macular Degeneration, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 69. This study's planned 62 months is above that.
Counting every sponsor, half of 161 studies reached it within 45 months; a quarter within 16 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
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LumiThera, Inc.