Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2): a Multicentre, Randomised, Sham-controlled, Double-masked, Clinical Device Trial.
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:
• 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 \[20/40 to 20/200\])
Locations
Other Locations
Australia
Adelaide Eye & Retina Centre
RECRUITING
Adelaide
Eye Clinic Albury-Wodonga
RECRUITING
Albury
Cerulea
RECRUITING
East Melbourne
Hobart Eye Surgeons
RECRUITING
Hobart
Sydney Eye Hospital
RECRUITING
Sydney
New Zealand
Southern Eye Specialist
RECRUITING
Christchurch
Auckland Eye Limited
RECRUITING
Remuera
United Kingdom
King's College Hospital
NOT_YET_RECRUITING
London
London North West University Healthcare
NOT_YET_RECRUITING
Middlesex
Swansea Bay University Local Health Board
NOT_YET_RECRUITING
Port Talbot
Contact Information
Primary
Meredith Mundy
mmundy@i-lumen.com.au
408-440-7049
Time Frame
Start Date: 2025-05-07
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Active i-Lumen AMD therapy
Active transpalpebral microcurrent therapy
Sham_comparator: Sham i-Lumen AMD therapy
Sham transpalpebral microcurrent therapy
Related Therapeutic Areas
Sponsors
Leads: i-Lumen Scientific AUS PTY LTD
Collaborators: i-Lumen Scientific, Inc.