NCT06662162 · i-Lumen Scientific AUS PTY LTD
Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration
(i-SIGHT2)
What this study is about
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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Manchester, Connecticut
- Lemont, Illinois
- Fort Worth, Texas
- Tyler, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations