Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Deā¦ (NCT06662162) | Clinical Trial Compass
RecruitingNot Applicable
Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration
United States, Australia100 participantsStarted 2025-05-07
Plain-language 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.
Who can participate
Age range60 Years
SexALL
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Key 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 ā¦