Clinical Research Directory
Browse clinical research sites, groups, and studies.
Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy
Sponsor: Okuvision GmbH
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.
Official title: Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy Under Everyday Conditions - a Multicentric, Randomized, Double-masked, Sham-controlled Pilot Study
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-04
Completion Date
2028-06
Last Updated
2026-04-15
Healthy Volunteers
No
Interventions
Transcorneal 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.
Transcorneal 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