NCT06662162

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: i-Lumen Scientific AUS PTY LTD · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	i-Lumen AMD	i-Lumen AMD transpalpebral microcurrent stimulation system

Timeline

• Start date: 2025-05-07
• Primary completion: 2027-03-31
• Completion: 2029-12-31
• First posted: 2024-10-28
• Last updated: 2026-04-14

Locations

10 sites across 4 countries: United States, Australia, New Zealand, United Kingdom

Regulatory

• FDA-regulated device study