Recruiting NCT06662162
Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: i-Lumen AMD.
- Who it may be relevant to
- Registry conditions: Age-Related Macular Degeneration, Age-related Macular Degeneration (ARMD), Intermediate AMD, Geographic Atrophy Secondary to Age-related Macular Degeneration. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, New Zealand, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2): a Multicentre, Randomised, Sham-controlled, Double-masked, Clinical Device Trial.
Overview
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.
Interventions
- Device i-Lumen AMD
i-Lumen AMD transpalpebral microcurrent stimulation system
Primary outcome measures
- Mean Change BCVA from Baseline [Time frame: Month 3]
Secondary outcome measures (2)
- Portion of per-eye Responders [Time frame: Month 3]
- Mean Change BCVA from Baseline [Time frame: Month 6]
Eligibility criteria
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 \[20/40 to 20/200\])
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Retina Consultants PC — Manchester
- University Retina & Macula Associates — Lemont
- Sierra Eye Associates — Reno
- Texas Retina Associates — Fort Worth
- Tyler Retina Research Insitute — Tyler
Australia · 4 centers
- Sydney Eye Hospital — Sydney
- Hobart Eye Surgeons — Hobart
- Adelaide Eye & Retina Centre — Adelaide
- Cerulea — East Melbourne
United Kingdom · 4 centers
- Queens University Belfast / Belfast City Hospital — Belfast
- King's College Hospital — London
- London North West University Healthcare — Middlesex
- Sunderland Eye Infirmary — Sunderland
New Zealand · 2 centers
- Auckland Eye Limited — Remuera
- Southern Eye Specialist — Christchurch
Identifiers
NCT: NCT06662162 · ILS-AMD-202