RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: i-Lumen Scientific AUS PTY LTD • ClinicalTrials.gov ID: NCT06662162

Registry updated: 2026-08-26

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Description

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.

Interventions

i-Lumen AMD (Device)
i-Lumen AMD transpalpebral microcurrent stimulation system

Eligibility 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.

Conditions

Age-Related Macular Degeneration Age-related Macular Degeneration (ARMD) Intermediate AMD Geographic Atrophy Secondary to Age-related Macular Degeneration

Locations

Retina Consultants San Diego — Poway, California, United States
Retina Consultants PC — Manchester, Connecticut, United States
University Retina & Macula Associates — Lemont, Illinois, United States
Sierra Eye Associates — Reno, Nevada, United States
Retina Associates of Cleveland — Beachwood, Ohio, United States
Texas Retina Associates — Fort Worth, Texas, United States
Tyler Retina Research Insitute — Tyler, Texas, United States
Cerulea — East Melbourne, Victoria, Australia
Auckland Eye Limited — Remuera, Auckland, New Zealand
Queens University Belfast / Belfast City Hospital — Belfast, United Kingdom
King's College Hospital — London, United Kingdom
London North West University Healthcare — Middlesex, United Kingdom
Sunderland Eye Infirmary — Sunderland, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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