Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorOkuvision GmbH
About this trial
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 criteria
Qualifiers
Willing and able to understand the study and provide informed consent
60 years of age or older
Diagnosis of geographic atrophy due to age-related macular degeneration confirmed by imaging
The affected area in the eye must be within a defined size range and clearly visible on imaging
Disqualifiers
History or presence of certain eye conditions (e.g. macular edema, abnormal blood vessel growth or related conditions, retinal detachment, blood vessel blockage) in the study eye
Previous major eye surgeries (including retinal surgery or vitrectomy)
Previous laser treatment or injections in the study eye
Any other eye condition that could interfere with vision tests, imaging or study results
Trial design
Treatments tested in this trial
- Transcorneal electrical stimulation (TES) with the OkuStim 2 System
- Transcorneal electrical stimulation (TES) with the OkuStim 2 System
Treatment groups
70 Participants
are divided into 3 treatment groupsSponsors and collaborators
Okuvision GmbH
Lead sponsor
CONVIDIA clinical research GmbH
Collaborator
Nubilaria Srl
Collaborator
TentaConsult Pharma & Med GmbH
Collaborator
Department of Ophthalmology, University Hospital Ulm, Germany
Collaborator
Department of Ophthalmology, Klinikum Stuttgart, Germany
Collaborator
Centre for Ophthalmology, University Hospital Tuebingen, Germany
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator
Department of Ophthalmology, Ludwig-Maximilians-University Munich, Germany
Collaborator
Steinbeis-Forschungszentrum, GRADE Reading Center
Collaborator
Clinical Study Core Unit SZB, Studienzentrum Bonn, University Hospital Bonn, Germany
Collaborator
Source ClinicalTrials.gov