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Clinical Trials in the USA / NCT06662162
Recruiting Not applicable

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

NCT06662162 · tracked via the Priya Life Science USA tracker
Sponsor
i-Lumen Scientific AUS PTY LTD
Phase
Not applicable
Started
2025-05-07
Last updated
2026-08-26

Condition(s) studied

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

Investigational drug(s) / intervention(s)

i-Lumen AMD

i-Lumen AMD: i-Lumen AMD transpalpebral microcurrent stimulation system

Study summary

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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
Retina Consultants San Diego Poway California Recruiting
Retina Consultants PC Manchester Connecticut Recruiting
University Retina & Macula Associates Lemont Illinois Recruiting
Sierra Eye Associates Reno Nevada Not Yet Recruiting
Retina Associates of Cleveland Beachwood Ohio Recruiting
Texas Retina Associates Fort Worth Texas Recruiting
Tyler Retina Research Insitute Tyler Texas Recruiting
Cerulea East Melbourne Victoria Active Not Recruiting
Auckland Eye Limited Remuera Auckland Recruiting
Queens University Belfast / Belfast City Hospital Belfast United Kingdom Recruiting
King's College Hospital London United Kingdom Recruiting
London North West University Healthcare Middlesex United Kingdom Recruiting
Sunderland Eye Infirmary Sunderland United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06662162 on ClinicalTrials.gov ↗ ← All trials in the USA