The first participant has been enrolled in the i-SIGHT2 study – an Australian-run clinical trial for the novel, non-invasive i-Lumen AMD System. The study is designed to evaluate vision improvement generated by the i-Lumen AMD system in patients with central vision loss due to intermediate and advanced non-exudative (dry) age-related macular degeneration (AMD).

The investigational device uses proprietary surface microcurrent stimulation therapy to repolarise the retinal pigment epithelium (RPE) and improve mitochondrial density and function. By targeting these underlying retinal structures, the i-Lumen AMD therapy has the potential to protect and improve photoreceptor function, thereby slowing disease progression and improving visual acuity.

The i-SIGHT2 study, now underway across multiple ophthalmic centres in Australia and New Zealand, and soon to be enrolling participants in the United Kingdom, will evaluate the safety and effectiveness of the i-Lumen AMD System. The study will measure improvements in visual acuity, quality of life, and disease progression.

i-Lumen recently completed the i-SIGHT clinical research study in the United States. The randomised, sham-controlled study enrolled 30 participants who completed the initial five-day treatment regimen with the i-Lumen AMD System, and two maintenance treatment days at the one and two month time points.

The participants were followed through to the month 12 time point (10 months post last treatment). At month three, one month after the last maintenance treatment, more than 50% of participants treated achieved an improvement in best corrected visual acuity (BCVA) of ≥2 lines of improvement from baseline.

“The enrolment and treatment of the first study participant is an exciting and encouraging step for i-Lumen’s research program,” said Timothy Jackson, Professor of Retinal Research at King’s College London and i-SIGHT2 Coordinating Investigator. “The prospect of a material vision gain, maintained over time, and delivered from a non-invasive treatment, is something of a holy grail for intermediate and dry AMD research. Given the high prevalence of AMD in so many countries, a positive result would have global impact.”

“Starting the i-SIGHT2 study is a significant achievement, and we are grateful to the study sites, physicians, and clinicians participating in this research,” said John VeLure, CEO, i-Lumen Scientific. “This milestone underscores our mission to transform vision care for people with intermediate to advanced dry AMD and ultimately preserve vision for the millions at risk.”

The i-Lumen AMD System was developed by i-Lumen Scientific, Inc. The i-SIGHT2 clinical research study is being conducted by its Australian subsidiary, i-Lumen Scientific Aus Pty Ltd.

For more information about the i-SIGHT2 study and site participation, contact info@i-lumen.com.au.