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Could a light beam slow vision loss? new trial tests laser therapy for AMD

NCT ID NCT07554690

Disease control Sponsor: Fondazione G.B. Bietti, IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study tests a non-invasive laser treatment called photobiomodulation for people with early age-related macular degeneration (AMD) who have a specific type of deposit in the eye called reticular pseudodrusen. The treatment uses low-energy light to stimulate cells and reduce inflammation, aiming to slow vision loss and improve sight in dim light. About 67 participants will receive either the real laser or a sham treatment, and be followed for 12 months.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 67 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

50 years and older

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: * Age ≥ 50 years * Diagnosis of reticular pseudodrusen secondary to age-related macular degeneration in the study eye * Best-corrected visual acuity (BCVA) between 20/20 and 20/400 (inclusive) * Ability and willingness to comply with study procedures and visits * Written informed consent obtained prior to any study procedures Exclusion Criteria: * Presence of geographic atrophy * Evidence of macular neovascularization * Any previous treatment for age-related macular degeneration, except for antioxidant supplementation * Media opacities that may interfere with retinal imaging assessments * Use of phototoxic medications (including certain antibiotics or chemotherapeutics) during PBM treatment * Any ocular or systemic treatment known to be toxic to the retina or optic nerve * History of uveitis (idiopathic or autoimmune) * Neovascular glaucoma * Glaucoma due to congenital anomalies * Glaucoma secondary to active uveitis * Any intraocular surgery within 3 months prior to enrollment in the study eye * Previous thermal laser treatment in the macular region of the study eye * History of vitrectomy, filtering surgery, corneal transplantation, or retinal detachment in the study eye * Previous therapeutic radiation to the ocular region or face * Women of childbearing potential not using effective contraception during the study treatment period

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Conditions

The condition(s) this trial relates to.

age-related macular degeneration macular degeneration reticular pseudodrusen

As listed by the trial registrant

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

AMD - 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

    1 site. 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

  • IRCCS Fondazione G.B.Bietti c/o Ospedale Britannico

    Roma, Italy, 00184, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.