Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2): a Multicentre, Randomised, Sham-controlled, Double-masked, Clinical Device Trial.
i-Lumen Scientific AUS PTY LTD
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.
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Devicei-Lumen AMD
i-Lumen AMD transpalpebral microcurrent stimulation system
Locations (13)
- Retina Consultants PCManchester, Connecticut
- University Retina & Macula AssociatesLemont, Illinois
- Texas Retina AssociatesFort Worth, Texas
- Tyler Retina Research InsituteTyler, Texas
- Sydney Eye HospitalSydney, New South Wales
- Hobart Eye SurgeonsHobart, Tasmania