Actively Recruiting
Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2): a Multicentre, Randomised, Sham-controlled, Double-masked Clinical Device Trial
Led by i-Lumen Scientific AUS PTY LTD · Updated on 2026-05-04
100
Participants Needed
13
Research Sites
143 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
Researchers are evaluating the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in people with intermediate to advanced nonexudative Age-related Macular Degeneration (AMD). This study is a randomized, sham-controlled clinical device trial designed to assess how this microcurrent therapy may affect vision in this patient group. The trial is led by i-Lumen Scientific AUS PTY LTD and includes participants aged 60 years or older. Participants will be assigned to receive either active transpalpebral microcurrent therapy using the i-Lumen AMD device or a sham (placebo) version of the therapy. The treatment regimen consists of an initial loading phase followed by seven maintenance sessions over 11 months. After completing the treatment sessions, participants will return monthly through Month 14, which is three months after the last treatment, for ongoing evaluation and monitoring. During the study, participants will undergo visual acuity testing to measure changes in Best Corrected Visual Acuity (BCVA) at Month 3 and Month 6 as primary and secondary outcomes. The study team will also assess the portion of eyes that respond to treatment at Month 3. Monthly visits will include evaluations and monitoring to track safety and effectiveness. The total study participation includes treatment over 11 months plus a 3-month post-treatment observation period, totaling 14 months.
CONDITIONS
Brief 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])
You will not qualify if you...
- Presence of any implanted electrical device including deep brain stimulator, hearing or visual implants, or cardiac defibrillator/pacemaker
- Implanted metallic device within 20 cm of the treatment or grounding electrode
- Uncontrolled diabetes with glycated haemoglobin (HbA1c) over 10%
- Current tobacco use or history of heavy smoking within the past 5 years
- Known severe allergy to fluorescein dye
- Severe dry eye requiring artificial tears more than six times a day or prescription drops
- History of seizure disorders, chronic migraines, or cluster headaches
- History or evidence of diabetic retinopathy in either eye
- Conditions predisposing to chorioretinal atrophy such as inherited retinal dystrophies
- History or evidence of exudative Age-related Macular Degeneration 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 history of trabeculectomy
- History of intraocular surgery other than cataract surgery within three months
- History of YAG laser posterior capsulotomy within one month
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 months
Participants receive active or sham transpalpebral microcurrent stimulation therapy using the i-Lumen AMD device.
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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