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Light pulses to the eye: a new hope against dry AMD?

NCT ID NCT06351605

Disease control Sponsor: LumiThera, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This study tests whether photobiomodulation (PBM), a light-based therapy delivered by the Valeda system, can safely improve vision in people with dry age-related macular degeneration (AMD). Researchers will collect data from 500 participants in routine clinical practice across Europe, the US, and other countries. The main goals are to see if the treatment changes visual acuity and to track any side effects. PBM uses specific wavelengths of light to stimulate cellular energy production, which may help slow the progression of dry AMD.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Photobiomodulation (PBM) delivered by the Valeda Light Delivery System, a device that applies pulsed light of three wavelengths to the eye.
What this could lead to
If it works, this could offer a non-invasive treatment to slow vision loss or improve sight in people with dry AMD, a common cause of blindness in older adults.
What could go wrong
This is a registry study, not a randomized controlled trial, so results may be less definitive. The treatment may not improve vision for everyone, and there is a small risk of eye discomfort or other side effects from the light.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

dry age related macular degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dry age-related macular degeneration

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Carolina Eyecare Physicians

    NOT_YET_RECRUITING

    Charleston, South Carolina, 29414, United States

  • Ichan School of Medicine at Mount Sinai

    NOT_YET_RECRUITING

    New York, New York, 10029, United States

  • Institutt for Oyehelse

    ACTIVE_NOT_RECRUITING

    Oslo, 0366, Norway

  • Pacific Northwest Retina

    NOT_YET_RECRUITING

    Silverdale, Washington, 98383, United States

  • Retina Associates of Kentucky

    NOT_YET_RECRUITING

    Lexington, Kentucky, 40509, United States

  • Retina Vitreous Associates Medical Group

    NOT_YET_RECRUITING

    Beverly Hills, California, 90211, United States

  • Valley Retina Institute

    RECRUITING

    McAllen, Texas, 78503, United States

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