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.
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])
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).
i-Lumen Scientific AUS PTY LTD
Lead sponsor
i-Lumen Scientific, Inc.
Collaborator