RecruitingNot ApplicableNCT07531927

Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy

Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy Under Everyday Conditions - a Multicentric, Randomized, Double-masked, Sham-controlled Pilot Study

Sponsor

Okuvision GmbH

Enrollment

70 participants

Start Date

May 5, 2026

Study Type

INTERVENTIONAL

Conditions

Geographic Atrophy secondary to Age Related Macular Degeneration

Summary

Geographic atrophy (GA) is a progressive eye disease that causes the degeneration of the retinal cells, particularly in the macula, leading to vision loss. The goal of this pilot study is to evaluate the safety and the effectiveness of transcorneal electrical stimulation (TES) therapy with the OkuStim 2 System in patients with geographic atrophy (GA). Researchers will compare the effects of two different electrical stimuli with a placebo to see if the stimuli are safe and can slow down the progression of the disease. Participants will be randomly assigned to one of these three groups: * TES-treatment with a rectangular stimulus * TES-treatment with a repetitive ramp stimulus * Placebo (sham) treatment Participants will apply the therapy at home, once a week for 30 minutes each over a duration of 1 year.

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Transcorneal electrical stimulation (TES) with the OkuStim 2 System and a medical device called Transcorneal electrical stimulation (TES) with the OkuStim 2 System for people with geographic atrophy secondary to age related macular degeneration. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscorneal electrical stimulation (TES) with the OkuStim 2 System

In TES therapy with the OkuStim 2 System, retinal stimulation is achieved through transcorneal current application: using a thread electrode, the OkuEl M, a weak current (≤ 1mA) is introduced onto the surface of the eye, which spreads through the eye towards the retina.

DEVICETranscorneal electrical stimulation (TES) with the OkuStim 2 System

Sham-stimulation will be performed once per week, for 30 minutes, for 12 months without effective stimulation

Locations(5)

Department of Ophthalmology, University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Department of Ophthalmology, Ludwig-Maximilians-University Munich

München, Germany

Department of Ophthalmology, Klinikum Stuttgart

Stuttgart, Germany

Centre for Ophthalmology, University Hospital Tuebingen

Tübingen, Germany

Department of Ophthalmology, University Hospital Ulm

Ulm, Germany

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NCT07531927

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