Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration
NCT ID: NCT06662162
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-05-07
2029-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active i-Lumen AMD therapy
Active transpalpebral microcurrent therapy
i-Lumen AMD
i-Lumen AMD transpalpebral microcurrent stimulation system
Sham i-Lumen AMD therapy
Sham transpalpebral microcurrent therapy
i-Lumen AMD
i-Lumen AMD transpalpebral microcurrent stimulation system
Interventions
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i-Lumen AMD
i-Lumen AMD transpalpebral microcurrent stimulation system
Eligibility Criteria
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Inclusion Criteria
* BCVA letter score of 35 to 70 letters (inclusive) (Snellen equivalent 6/12 to 6/60 \[20/40 to 20/200\])
Exclusion Criteria
* 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.
60 Years
ALL
No
Sponsors
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i-Lumen Scientific, Inc.
INDUSTRY
i-Lumen Scientific AUS PTY LTD
INDUSTRY
Responsible Party
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Principal Investigators
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Meredith Mundy
Role: STUDY_DIRECTOR
i-Lumen Scientific AUS PTY LTD
Locations
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Eye Clinic Albury-Wodonga
Albury, New South Wales, Australia
Sydney Eye Hospital
Sydney, New South Wales, Australia
Hobart Eye Surgeons
Hobart, Tasmania, Australia
Adelaide Eye & Retina Centre
Adelaide, Victoria, Australia
Cerulea
East Melbourne, Victoria, Australia
Auckland Eye Limited
Remuera, Auckland, New Zealand
Southern Eye Specialist
Christchurch, , New Zealand
King's College Hospital
London, , United Kingdom
London North West University Healthcare
Middlesex, , United Kingdom
Swansea Bay University Local Health Board
Port Talbot, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Cherie Research Coordinator
Role: primary
i-SIGHT2 MRG Coordinator
Role: primary
Jackie Research Coordinator
Role: primary
Kerin Research Coordinator
Role: primary
Regina Research Coordinator
Role: primary
Alice Research Coordinator
Role: primary
Marie Research Coordinator
Role: primary
Nikki Research Coordinator
Role: primary
Sandali Research Coordinator
Role: primary
Rebecca Research Coordinator
Role: primary
Other Identifiers
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ILS-AMD-202
Identifier Type: -
Identifier Source: org_study_id