Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration
i-SIGHT2
1 other identifier
interventional
100
4 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2025
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2024
CompletedFirst Posted
Study publicly available on registry
October 28, 2024
CompletedStudy Start
First participant enrolled
May 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
May 4, 2026
April 1, 2026
1.9 years
October 25, 2024
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change BCVA from Baseline
Mean change in per-eye (treated study eye \[unilateral\] or treated primary study eye \[bilateral\]) from Baseline in distance BCVA letter score on the ETDRS VA chart, active vs sham.
Month 3
Secondary Outcomes (2)
Portion of per-eye Responders
Month 3
Mean Change BCVA from Baseline
Month 6
Study Arms (2)
Active i-Lumen AMD therapy
EXPERIMENTALActive transpalpebral microcurrent therapy
Sham i-Lumen AMD therapy
SHAM COMPARATORSham transpalpebral microcurrent therapy
Interventions
i-Lumen AMD transpalpebral microcurrent stimulation system
Eligibility Criteria
You may qualify if:
- 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 \[20/40 to 20/200\])
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- i-Lumen Scientific AUS PTY LTDlead
- i-Lumen Scientific, Inc.collaborator
Study Sites (13)
Retina Consultants PC
Manchester, Connecticut, 06042, United States
University Retina & Macula Associates
Lemont, Illinois, 60439, United States
Texas Retina Associates
Fort Worth, Texas, 76104, United States
Tyler Retina Research Insitute
Tyler, Texas, 75703, United States
Sydney Eye Hospital
Sydney, New South Wales, 2000, Australia
Hobart Eye Surgeons
Hobart, Tasmania, 7000, Australia
Adelaide Eye & Retina Centre
Adelaide, Victoria, 5000, Australia
Cerulea
East Melbourne, Victoria, Australia
Auckland Eye Limited
Remuera, Auckland, 1050, New Zealand
Southern Eye Specialist
Christchurch, New Zealand
King's College Hospital
London, SE5 9RS, United Kingdom
London North West University Healthcare
Middlesex, HA1 3UJ, United Kingdom
Sunderland Eye Infirmary
Sunderland, SR2 9HP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Meredith Mundy
i-Lumen Scientific AUS PTY LTD
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2024
First Posted
October 28, 2024
Study Start
May 7, 2025
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
December 31, 2029
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share