Actively Recruiting
Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration
Led by i-Lumen Scientific AUS PTY LTD · Updated on 2026-05-04
100
Participants Needed
13
Research Sites
242 weeks
Total Duration
On this page
Sponsors
I
i-Lumen Scientific AUS PTY LTD
Lead Sponsor
I
i-Lumen Scientific, Inc.
Collaborating Sponsor
AI-Summary
What this Trial 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. * Participants will return monthly through Month 14 (3 months post-last treatment) for evaluation and monitoring.
CONDITIONS
Official Title
Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of at least one large druse greater than 125 microns in diameter due to age-related macular degeneration.
- Best corrected visual acuity (BCVA) letter score between 35 and 70 letters inclusive (Snellen equivalent 6/12 to 6/60 [20/40 to 20/200]).
- Age 60 years or older.
You will not qualify if you...
- Presence of any implanted electrical device including deep brain stimulator, hearing or visual implants (cochlear implant, auditory brainstem implant, retinal prostheses), or cardiac defibrillator/pacemaker.
- Implanted metallic device within 20 cm of the treatment electrode (study eye) or grounding electrode (back of the neck).
- Uncontrolled diabetes with glycated haemoglobin (HbA1c) greater than 10% (13.3 mmol/L).
- Current tobacco or tobacco-related product use or a history of heavy smoking within the past 5 years (more than half a pack of cigarettes per day).
- Known severe allergy to fluorescein dye.
- Severe dry eye requiring artificial tears more than six times a day or prescription drops (Restasis, Xiidra, or Cequa).
- History of seizure disorders, chronic migraines, or cluster headaches.
- History or evidence of diabetic retinopathy in either eye.
- Other conditions predisposing to chorioretinal atrophy such as inherited retinal dystrophy (e.g., Stargardt's disease, Best's disease, pattern dystrophy, central areolar choroidal dystrophy).
- History or evidence of exudative AMD in the study eye.
- Geographic atrophy involving the foveal centre.
- History of intravitreal injections for geographic atrophy.
- Treatment with photobiomodulation therapy or short pulse laser within 12 months prior to screening.
- Glaucoma requiring three or more medications or drops per day, or history of trabeculectomy.
- History of any intraocular surgery excluding cataract surgery performed more than 3 months before screening.
- History of YAG laser posterior capsulotomy less than 1 month before screening.
- Visually significant cataracts or posterior capsular opacification.
- History of amblyopia.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Retina Consultants PC
Manchester, Connecticut, United States, 06042
Not Yet Recruiting
2
University Retina & Macula Associates
Lemont, Illinois, United States, 60439
Not Yet Recruiting
3
Texas Retina Associates
Fort Worth, Texas, United States, 76104
Not Yet Recruiting
4
Tyler Retina Research Insitute
Tyler, Texas, United States, 75703
Not Yet Recruiting
5
Sydney Eye Hospital
Sydney, New South Wales, Australia, 2000
Actively Recruiting
6
Hobart Eye Surgeons
Hobart, Tasmania, Australia, 7000
Actively Recruiting
7
Adelaide Eye & Retina Centre
Adelaide, Victoria, Australia, 5000
Actively Recruiting
8
Cerulea
East Melbourne, Victoria, Australia
Actively Recruiting
9
Auckland Eye Limited
Remuera, Auckland, New Zealand, 1050
Actively Recruiting
10
Southern Eye Specialist
Christchurch, New Zealand
Actively Recruiting
11
King's College Hospital
London, United Kingdom, SE5 9RS
Actively Recruiting
12
London North West University Healthcare
Middlesex, United Kingdom, HA1 3UJ
Actively Recruiting
13
Sunderland Eye Infirmary
Sunderland, United Kingdom, SR2 9HP
Actively Recruiting
Research Team
M
Meredith Mundy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here