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Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration
Sponsor: 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.
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.
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-05-07
Completion Date
2029-12-31
Last Updated
2026-01-29
Healthy Volunteers
No
Conditions
Interventions
i-Lumen AMD
i-Lumen AMD transpalpebral microcurrent stimulation system
Locations (9)
Eye Clinic Albury-Wodonga
Albury, New South Wales, Australia
Sydney Eye Hospital
Sydney, New South Wales, Australia
Hobart Eye Surgeons
Hobart, Tasmania, Australia
Adelaide Eye & Retina Centre
Adelaide, Victoria, Australia
Cerulea
East Melbourne, Victoria, Australia
Auckland Eye Limited
Remuera, Auckland, New Zealand
Southern Eye Specialist
Christchurch, New Zealand
King's College Hospital
London, United Kingdom
London North West University Healthcare
Middlesex, United Kingdom