Microcurrent therapy for advanced age-related macular degeneration
Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2): a Multicentre, Randomised, Sham-controlled, Double-masked, Clinical Device Trial.
This study is testing a new device that uses microcurrents to see if it can improve vision and eye health in people with advanced age-related macular degeneration.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | i-Lumen Scientific AUS PTY LTD Industry-sponsored |
| Locations | 13 sites (Manchester, Connecticut and 12 other locations) |
| Trial ID | NCT06662162 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device in patients with intermediate to advanced nonexudative age-related macular degeneration (AMD). Participants will undergo an initial loading regimen followed by seven maintenance sessions over 11 months, with monthly evaluations for three months post-treatment. The study aims to determine how this therapy impacts vision and overall eye health in affected individuals.
Who should consider this trial
Good fit: Ideal candidates are individuals with intermediate to advanced nonexudative AMD, specifically those with large drusen and a visual acuity letter score between 35 to 70.
Not a fit: Patients with implanted electrical devices, uncontrolled diabetes, or severe dry eye may not benefit from this therapy.
Why it matters
Potential benefit: If successful, this therapy could improve vision and quality of life for patients suffering from advanced stages of age-related macular degeneration.
How similar studies have performed: While this approach is relatively novel, similar studies exploring microcurrent therapy for eye conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Manchester, Connecticut and 12 other locations
- Retina Consultants PC — Manchester, Connecticut, United States (Not_yet_recruiting)
- University Retina & Macula Associates — Lemont, Illinois, United States (Not_yet_recruiting)
- Texas Retina Associates — Fort Worth, Texas, United States (Not_yet_recruiting)
- Tyler Retina Research Insitute — Tyler, Texas, United States (Not_yet_recruiting)
- Sydney Eye Hospital — Sydney, New South Wales, Australia (Recruiting)
- Hobart Eye Surgeons — Hobart, Tasmania, Australia (Recruiting)
- Adelaide Eye & Retina Centre — Adelaide, Victoria, Australia (Recruiting)
- Cerulea — East Melbourne, Victoria, Australia (Recruiting)
- Auckland Eye Limited — Remuera, Auckland, New Zealand (Recruiting)
- Southern Eye Specialist — Christchurch, New Zealand (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)
Study contacts
- Study coordinator: Meredith Mundy
- Email: mmundy@i-lumen.com.au
- Phone: 408-440-7049
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.