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Could a tiny zap save your sight? new device trial for dry AMD

NCT ID NCT06662162

Disease control Sponsor: i-Lumen Scientific AUS PTY LTD 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 8 times

Summary

This study tests a device that delivers tiny electrical pulses through the eyelid to the back of the eye. The goal is to see if it can safely slow vision loss or improve sight in people with intermediate to advanced dry age-related macular degeneration. One hundred participants will receive either the real device or a sham (inactive) device over 11 months, with follow-up for 3 more months.

What this could mean

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

Active substance
i-Lumen AMD transpalpebral microcurrent stimulation device
What this could lead to
If it works, this could offer a non-invasive way to slow vision loss and possibly improve sight in people with dry age-related macular degeneration.
What could go wrong
This is an early device trial with only 100 participants. The treatment may not improve vision better than a sham device, and long-term benefits or risks are unknown.

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 100 people

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

Started

May 2025

Expected to finish

Dec 2029

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.

Ages

60 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.

Key Inclusion Criteria: * Presence of at least one large druse \>125 microns in diameter due to AMD. * BCVA letter score of 35 to 70 letters (inclusive) (Snellen equivalent 6/12 to 6/60 \[20/40 to 20/200\]) Key Exclusion Criteria: * Any implanted electrical device(s) including deep brain stimulator, hearing or visual implants (i.e., cochlear implant, auditory brainstem implant, retinal prostheses), and/or cardiac defibrillator/pacemaker. * Implanted metallic device within 20 cm of the Treatment electrode (study eye(s)) and/or the grounding electrode (base of the hairline on the back of the neck). * Uncontrolled diabetes, defined as glycated haemoglobin (HbA1c) \>10% (13.3 mmol/L). * Current tobacco or tobacco-related product use or history within the past 5 years of heavy smoking (defined as, on average, more than half a pack of cigarettes per day). * Known severe allergy to fluorescein dye. * Medical diagnosis of severe dry eye defined as requiring either artificial tears more than six (6) times a day or prescription drops (i.e., Restasis, Xiidra, or Cequa). * History of seizure disorders, chronic migraines and/or cluster headaches. * History and/or evidence of diabetic retinopathy in either eye as assessed by CF, fundus fluorescein angiography (FA), and OCT, to be confirmed by the Central Reading Centre. * Other conditions which pre-dispose to chorioretinal atrophy such as inherited retinal dystrophy (i.e., Stargardt's disease, Best's disease, pattern dystrophy, central areolar choroidal dystrophy, etc.). * History and/or evidence of exudative AMD in the study eye as assessed by CF, FA (or OCT-A ), and OCT, to be confirmed by Central Reading Centre. * GA involving the foveal centre, as assessed by the Central Reading Centre using AF and OCT. * History of intravitreal injections for GA (e.g., Syfovre or Izervay). * Treatment with photobiomodulation (PBM) therapy or short pulse laser within 12 months prior to screening. * Glaucoma requiring ≥3 medications and/or drops per day, or history of trabeculectomy. * History of any kind of intraocular surgery, excluding cataract surgery performed ≥3 months from Screening. * History of yttrium aluminium garnet (YAG) laser posterior capsulotomy \<1 month from Screening. * Visually significant cataracts and/or visually significant posterior capsular opacification. * History of amblyopia.

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Conditions

The condition(s) this trial relates to.

age-related macular degeneration dry age related macular degeneration Geographic Atrophy macular degeneration

As listed by the trial registrant

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

Age related macular degeneration (ARMD) Age-related macular degeneration Geographic atrophy secondary to age-related macular degeneration Intermediate AMD

How to take part

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

  1. The places running it

    12 sites in 3 countries. 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

  • Auckland Eye Limited

    RECRUITING

    Remuera, Auckland, 1050, New Zealand

  • Cerulea

    ACTIVE_NOT_RECRUITING

    East Melbourne, Victoria, Australia

  • King's College Hospital

    RECRUITING

    London, SE5 9RS, United Kingdom

  • London North West University Healthcare

    RECRUITING

    Middlesex, HA1 3UJ, United Kingdom

  • Queens University Belfast / Belfast City Hospital

    RECRUITING

    Belfast, United Kingdom

  • Retina Associates of Cleveland

    RECRUITING

    Beachwood, Ohio, 44122, United States

  • Retina Consultants PC

    RECRUITING

    Manchester, Connecticut, 06042, United States

  • Retina Consultants San Diego

    RECRUITING

    Poway, California, 92064, United States

  • Sierra Eye Associates

    NOT_YET_RECRUITING

    Reno, Nevada, 89502, United States

  • Sunderland Eye Infirmary

    RECRUITING

    Sunderland, SR2 9HP, United Kingdom

  • Texas Retina Associates

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Tyler Retina Research Insitute

    RECRUITING

    Tyler, Texas, 75703, United States

  • University Retina & Macula Associates

    RECRUITING

    Lemont, Illinois, 60439, United States

More trials for these conditions

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