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

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.

Conditions

• Geographic Atrophy Secondary to Age-related Macular Degeneration

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

Sponsors & Collaborators

• CONVIDIA clinical research GmbH

  collaborator UNKNOWN

• Nubilaria Srl

  collaborator UNKNOWN

• TentaConsult Pharma & Med GmbH

  collaborator UNKNOWN

• Department of Ophthalmology, University Hospital Ulm, Germany

  collaborator UNKNOWN

• Department of Ophthalmology, Klinikum Stuttgart, Germany

  collaborator UNKNOWN

• Centre for Ophthalmology, University Hospital Tuebingen, Germany

  collaborator UNKNOWN

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• Department of Ophthalmology, Ludwig-Maximilians-University Munich, Germany

  collaborator UNKNOWN

• Steinbeis-Forschungszentrum, GRADE Reading Center

  collaborator UNKNOWN

• Clinical Study Core Unit SZB, Studienzentrum Bonn, University Hospital Bonn, Germany

  collaborator UNKNOWN

• Okuvision GmbH

  lead INDUSTRY

Principal Investigators

• Florian Gekeler, Prof. Dr. · Department of Ophthalmology, Klinikum Stuttgart, Germany

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-05

Primary Completion

2028-06-30

Completion

2028-06-30

Countries

• Germany

Study Locations