Clinical Trials for Noninvasive Dry AMD Therapy Expand to the US
The i-SIGHT2 pivotal clinical trial has officially begun in the United States, with the first patient randomized at Texas Retina Associates in Fort Worth. This study evaluates the i-Lumen AMD System, an investigational, office-based device designed to treat intermediate to advanced dry age-related macular degeneration (AMD). The trial, which previously launched in the United Kingdom, aims to determine if low-level microcurrent stimulation delivered through the eyelid can restore retinal electrophysiology and improve visual function, according to i-Lumen Scientific.
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How Bioelectric Therapy Targets Dry AMD
The i-Lumen AMD System operates on a bioelectric mechanism intended to address the underlying cellular dysfunction associated with dry AMD. According to the company, the device delivers microcurrent stimulation to the eye, which is designed to increase transepithelial potential and repolarize retinal pigment epithelium (RPE) cells. The goal is to restore retinal electrophysiologic signaling, thereby improving photoreceptor cell function.
By focusing on the electrical environment of the retina, the therapy seeks to stabilize or improve vision in patients where structural biomarkers for photoreceptor health have begun to decline. These mechanisms were initially explored in the i-SIGHT feasibility study, which concluded last year and provided the data necessary to initiate the current, larger-scale pivotal trial.
Comparing Feasibility Results and Pivotal Trial Goals
In the earlier feasibility study, researchers observed improvements in visual function, retinal electrophysiology, and structural biomarkers in treated eyes. The pivotal trial is now tasked with confirming these results in a randomized, sham-controlled environment—the gold standard for clinical evidence.
According to John VeLure, CEO and president of i-Lumen Scientific, the company is focusing on addressing the “significant unmet need” for patients with dry AMD. By comparing the treatment against a sham control, the study aims to isolate the specific impact of the microcurrent stimulation, ensuring that observed benefits are tied directly to the bioelectric intervention rather than external variables.
FAQ: Understanding the i-SIGHT2 Clinical Trial
- What is the i-SIGHT2 trial? It is a randomized, sham-controlled pivotal study evaluating the safety and effectiveness of the i-Lumen AMD System for dry AMD.
- How does the i-Lumen AMD System work? The office-based device delivers low-level microcurrent stimulation through the eyelid to repolarize RPE cells and improve retinal signaling.
- Who is eligible for this study? The trial targets patients with intermediate to advanced dry AMD. Recruitment is managed through clinical sites like Texas Retina Associates.
- Is this treatment invasive? No, the therapy is described as noninvasive and is administered in an office-based setting.
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