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Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration

Sponsor: i-Lumen Scientific AUS PTY LTD

NCT ID: NCT06662162

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
i-Lumen AMD (device)
How long the study runs
Study runs about 55 months (dates as stated)
About the drug or intervention
i-Lumen AMD — device: i-Lumen AMD transpalpebral microcurrent stimulation system
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at a treatment called microcurrent stimulation therapy for people with intermediate to advanced 'dry' age-related macular degeneration (AMD) — an eye condition that can blur central vision as we get older. Microcurrent stimulation uses very tiny electrical currents. The sponsor is i-Lumen Scientific AUS PTY LTD. The aim is not fully described in the data provided — ask the trial team for more details.

Who can take part

  • Age-related macular degeneration with at least one large drusen (fatty deposit) larger than 125 microns in the eye
  • Vision between 6/12 and 6/60 on a Snellen chart (a letter score of 35 to 70)

Who may not be able to

  • Any implanted electrical device, such as a pacemaker, defibrillator, cochlear implant or retinal implant
  • Metal implants near the eye being treated or near the back of the neck where a grounding pad sits
  • Poorly controlled diabetes (HbA1c above 10%)
  • Currently smoking, or a history of heavy smoking (more than half a pack a day) within the past 5 years
  • Severe allergy to fluorescein dye (used in some eye tests)
  • Severe dry eye needing artificial tears more than 6 times a day or prescription dry-eye drops
  • History of seizures, chronic migraines or cluster headaches
  • Diabetic retinopathy (eye damage from diabetes) in either eye
  • Other eye conditions that cause similar damage, such as Stargardt's disease or Best's disease
  • Wet AMD in the study eye
  • Geographic atrophy (advanced cell loss) affecting the very centre of the retina
  • Previous eye injections for geographic atrophy, such as Syfovre or Izervay
  • Light therapy (photobiomodulation) or short pulse laser treatment in the past 12 months
  • Glaucoma needing 3 or more medications a day, or previous glaucoma surgery (trabeculectomy)
  • Any eye surgery in the past, except cataract surgery done at least 3 months ago
  • YAG laser capsulotomy within the past month
  • Cataracts or clouding that significantly affects vision
  • Lazy eye (amblyopia)

What taking part involves

  • • Microcurrent stimulation therapy, which uses very small electrical currents applied near the eye — Not stated — ask the trial team for details on how it is given

Time commitment: Not stated — ask the trial team about the number of visits, how long the trial lasts and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
60 Years and over
Who
All
Number of participants
100
Started
2025-05-07
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for age-related macular degeneration
  • • NA - 100 participants
  • • The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative AMD

Who can take part?

  • • Ages 60 Years and over
  • • Diagnosed with age-related macular degeneration

Where?

  • • Belfast - Queens University Belfast / Belfast City Hospital
  • • London - King's College Hospital
  • • Middlesex - London North West University Healthcare
  • • Sunderland - Sunderland Eye Infirmary

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative AMD. Participants will: * Undergo an initial loading regimen, followed by 7 maintenance over the course of 11 months. * Participants will return monthly through Month 14 (3 months post-last treatment) for evaluation and monitoring.

Age-Related Macular DegenerationAge-related Macular Degeneration (ARMD)Intermediate AMDGeographic Atrophy Secondary to Age-related Macular Degeneration

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 60 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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 \[20/40 to 20/200\])

Who cannot take part

  • ✗Implanted metallic device within 20 cm of the Treatment electrode (study eye(s)) and/or the grounding electrode...
  • ✗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...
  • ✗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...
See the full criteria
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.

Where Is This Study? (4 UK sites)

Queens University Belfast / Belfast City Hospital

Belfast, United Kingdom

Recruiting
Site contact (verified)
Tunde PetoPrincipal Investigator
Therese Research Coordinator+44 02895 040342t.kearney@qub.ac.uk

King's College Hospital

London SE5 9RS, United Kingdom

Recruiting
Site contact (verified)
Timothy Jackson, PhD, FRCOphthPrincipal Investigator
Nikki Research Coordinator+44 203 299 7791noimottimson@nhs.net

London North West University Healthcare

Middlesex HA1 3UJ, United Kingdom

Recruiting
Site contact (verified)
Christiana Dinah, BSc, MB BS, MRes, FRCOphthPrincipal Investigator

Sunderland Eye Infirmary

Sunderland SR2 9HP, United Kingdom

Recruiting
Site contact (verified)
Ajay KotagiriPrincipal Investigator
SEI Research Nurses Research Coordinator0191 5699074stsft.seiresearchnurses@nhs.net

How to Get in Touch

Meredith Mundy

Sponsor contact

CONTACT

408-440-7049 mmundy@i-lumen.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08