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RECRUITING
NCT06662162
NA

Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration

Sponsor: i-Lumen Scientific AUS PTY LTD

View on ClinicalTrials.gov

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

Interventions

DEVICE

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