i-Lumen Reports Dry AMD Signals in i-SIGHT Feasibility Study

Study tested noninvasive retinal stimulation

The multicenter i-SIGHT trial evaluated the i-Lumen AMD System in patients with vision loss caused by intermediate to advanced nonexudative, or dry, age-related macular degeneration. The study enrolled 30 participants across 10 U.S. retina centers and assessed safety, visual function, retinal electrophysiology and retinal structural biomarkers.

Participants completed an initial 5-day treatment regimen, followed by one-day treatment visits at Months 1 and 2. They were followed through the Month 12 time point. The investigational device delivers low-level microcurrent stimulation through the eyelid, with the intended effect of influencing retinal bioelectrical signaling.

According to i-Lumen, proposed mechanisms include restoration of the retinal pigment epithelium's transepithelial electrical potential, which may support retinal homeostasis and photoreceptor function.

Results included visual and imaging signals

The mean change from baseline for the active study eye was +9.62 EDTRS letters at Month 3. In exploratory analyses, active study eyes showed an +8.54 ETDRS-letter advantage relative to untreated fellow eyes at Month 3, and a +3.9 ETDRS-letter advantage compared with sham.

More than 50% of treated participants achieved a ≥10-letter improvement in best-corrected visual acuity at one or more follow-up visits between Months 2 and 12. Improvements in photoreceptor response time, measured through multifocal electroretinography, were associated with improvements in visual acuity.

Exploratory optical coherence tomography analyses showed improvement in ellipsoid zone integrity during the treatment period. The maximum observed improvement was 47.6% by week 2, with a sustained improvement of 39% by Month 3.

No unanticipated device-related adverse events were reported, and overall adverse event rates were comparable between the active and sham groups.

Larger i-SIGHT2 trial is enrolling

The findings were presented by Sophie J. Bakri, MD, MBA, Professor and Chair of Ophthalmology at Mayo Clinic, following the 2026 Clinical Trials at the Summit Retina meeting.

“While the study was not designed to establish definitive efficacy, the signals observed in visual acuity, retinal electrophysiology, and imaging biomarkers support further evaluation in larger controlled clinical trials,” Bakri said.

i-Lumen has initiated the larger pivotal i-SIGHT2 Study and is currently enrolling participants in the US and the UK. The company described the study as an important step toward potential treatment options for intermediate to advanced dry AMD, where it says significant unmet need remains.

The i-Lumen AMD System remains under clinical investigation. It has not been approved by the U.S. Food and Drug Administration or any other regulatory authority for commercial use. The company also cautioned that feasibility-study results may not predict outcomes in larger clinical trials.