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NCT06662162NARecruiting

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

i-Lumen Scientific AUS PTY LTD

Start Date

5/7/2025

Completion Date

12/31/2029

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 Criteria

Age Range: 60 years to No maximum

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.

Interventions

DEVICE

i-Lumen AMD

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Conditions

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

Locations

Retina Consultants PC

Manchester, Connecticut 06042

United States

University Retina & Macula Associates

Lemont, Illinois 60439

United States

Sierra Eye Associates

Reno, Nevada 89502

United States

Texas Retina Associates

Fort Worth, Texas 76104

United States

Tyler Retina Research Insitute

Tyler, Texas 75703

United States

Sydney Eye Hospital

Sydney, New South Wales 2000

Australia

Hobart Eye Surgeons

Hobart, Tasmania 7000

Australia

Adelaide Eye & Retina Centre

Adelaide, Victoria 5000

Australia

Cerulea

East Melbourne, Victoria

Australia

Auckland Eye Limited

Remuera, Auckland 1050

New Zealand

Southern Eye Specialist

Christchurch,

New Zealand

Queens University Belfast / Belfast City Hospital

Belfast,

United Kingdom

King's College Hospital

London, SE5 9RS

United Kingdom

London North West University Healthcare

Middlesex, HA1 3UJ

United Kingdom

Sunderland Eye Infirmary

Sunderland, SR2 9HP

United Kingdom