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RECRUITING
NCT07531927
NA

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

Sponsor: Okuvision GmbH

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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