Study of i-Lumen Microcurrent Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration A Multicenter, Randomized, Sham-Controlled, Double-Masked Clinical Trial

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in people with intermediate to advanced nonexudative age-related macular degeneration AMD. This clinical device trial is randomized, sham-controlled, and double-masked to compare active microcurrent therapy with a sham treatment. The study is designed to better understand how this device may affect vision in this patient group. Participants will start with an initial loading phase of the i-Lumen AMD therapy, followed by seven maintenance treatments over about 11 months. The treatments involve using the transpalpebral microcurrent stimulation system applied near the eye. There is a comparison between active therapy and a sham placebo-like therapy to assess differences in outcomes. After completing treatments, participants will have monthly visits through Month 14, which is three months after the last treatment, for monitoring and evaluation. During the study, participants will have their vision assessed regularly, focusing on best-corrected visual acuity BCVA changes from baseline at 3 months as the primary outcome. Other measures include the portion of eyes responding to treatment and BCVA changes at 6 months. Monthly visits allow for ongoing safety monitoring and effectiveness assessments. Total participation lasts over a year, including treatment and follow-up periods, to observe any lasting effects or changes in vision.

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