Recruiting

PBM

Sponsor:

LumiThera, Inc.

Code:

NCT06351605

Conditions

Dry Age-related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Valeda® Light Delivery System

Study Details

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.

Conditions

Dry Age-related Macular Degeneration

Study ID

NCT06351605

Start date

Sep 1, 2023

Status verified date

Aug, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

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).

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 ]
  • Number of Adverse Events Associated with PBM Treatment [ Time Frame: Up to Month 31/exit ]

Central Contacts and Locations

Central contacts

Alcon Call Center

1-888-451-3937alcon.medinfo@alcon.com

Locations

Valley Retina Institute

Recruiting

McAllen, Texas, United States, 78503

More Information

Sponsor

LumiThera, Inc.

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by LumiThera, Inc. on 2026-09-02.