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 (13) 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
United States
California
Retina Consultants San Diego
RECRUITING
Poway
Connecticut
Retina Consultants PC
RECRUITING
Manchester
Illinois
University Retina & Macula Associates
RECRUITING
Lemont
Nevada
Sierra Eye Associates
NOT_YET_RECRUITING
Reno
Ohio
Retina Associates of Cleveland
RECRUITING
Beachwood
Texas
Texas Retina Associates
RECRUITING
Fort Worth
Tyler Retina Research Insitute
RECRUITING
Tyler
Other Locations
Australia
Cerulea
ACTIVE_NOT_RECRUITING
East Melbourne
New Zealand
Auckland Eye Limited
RECRUITING
Remuera
United Kingdom
Queens University Belfast / Belfast City Hospital
RECRUITING
Belfast
King's College Hospital
RECRUITING
London
London North West University Healthcare
RECRUITING
Middlesex
Sunderland Eye Infirmary
RECRUITING
Sunderland
Contact Information
Primary
Meredith Mundy
mmundy@i-lumen.com
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.