RecruitingNot ApplicableNCT06662162

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

Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2): a Multicentre, Randomised, Sham-controlled, Double-masked, Clinical Device Trial.

Sponsor

i-Lumen Scientific AUS PTY LTD

Enrollment

100 participants

Start Date

May 7, 2025

Study Type

INTERVENTIONAL

Conditions

Geographic Atrophy secondary to Age Related Macular Degeneration Age-Related Macular Degeneration Intermediate AMD Age-related Macular Degeneration (ARMD)

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

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called i-Lumen AMD for people with age-related macular degeneration, age-related macular degeneration (armd), and other related conditions. The study is currently recruiting participants at 13 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEi-Lumen AMD

i-Lumen AMD transpalpebral microcurrent stimulation system

Locations(13)

Retina Consultants PC

Manchester, Connecticut, United States

University Retina & Macula Associates

Lemont, Illinois, United States

Texas Retina Associates

Fort Worth, Texas, United States

Tyler Retina Research Insitute

Tyler, Texas, United States

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

Sunderland Eye Infirmary

Sunderland, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06662162

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