Clinical Trial

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

Study acronym: TES-GAP
Recruiting
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2026-04-13; most recent amendment 2026-05-06.
Trial Details
NCT Number NCT07531927
Lead Sponsor Okuvision GmbH
Collaborators: CONVIDIA clinical research GmbH, Nubilaria Srl, TentaConsult Pharma & Med GmbH, Department of Ophthalmology, University Hospital Ulm, Germany, Department of Ophthalmology, Klinikum Stuttgart, Germany, Centre for Ophthalmology, University Hospital Tuebingen, Germany, Universitätsklinikum Hamburg-Eppendorf, Department of Ophthalmology, Ludwig-Maximilians-University Munich, Germany, Steinbeis-Forschungszentrum, GRADE Reading Center, Clinical Study Core Unit SZB, Studienzentrum Bonn, University Hospital Bonn, Germany
Conditions Geographic Atrophy Secondary to Age-related Macular Degeneration
Enrollment 70 participants
Start Date 2026-05-05
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-28