NCT06662162 Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration
| NCT ID | NCT06662162 |
| Status | Recruiting |
| Phase | — |
| Sponsor | i-Lumen Scientific AUS PTY LTD |
| Condition | Age-Related Macular Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-05-07 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-05-07 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Meredith Mundy
STUDY DIRECTOR
i-Lumen Scientific, Inc.
Frequently Asked Questions
Who can join the NCT06662162 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Age-Related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06662162 currently recruiting?
Yes, NCT06662162 is actively recruiting participants. Contact the research team at mmundy@i-lumen.com for enrollment information.
Where is the NCT06662162 trial being conducted?
This trial is being conducted at Poway, United States, Manchester, United States, Lemont, United States, Reno, United States and 9 additional locations.
Who is sponsoring the NCT06662162 clinical trial?
NCT06662162 is sponsored by i-Lumen Scientific AUS PTY LTD. The principal investigator is Meredith Mundy at i-Lumen Scientific, Inc.. The trial plans to enroll 100 participants.