Dry Age-related Macular Degeneration
Conditions
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.
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.
Interventions
DEVICEValeda® 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).
Sponsors
LumiThera, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Acuity from Baseline at each Treatment Visit | 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 | Up to Month 31/exit | The number of adverse events associated with PBM treatment will be reported. |
Countries
Norway, United States
Contacts
CONTACTAlcon Call Center
STUDY_DIRECTORSr. Principal Clinical Trial Operations, Surgical
Alcon Research, LLC
Outcome results
None listed