Interventional Recruiting
NCT07531927 on ClinicalTrials.gov
Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy
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
- 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
- Enrollment: 70 (Estimated)
- Study start: 2026-05-05 (Actual)
- Primary completion: 2028-06-01 (Estimated)
- Study completion: 2028-06-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- InterventionModelDescription: Patients are assigned 1:1:1 to one of three different groups: Sham group (sham treatment), biphasic rectangular pulses, or repetitive ramp stimulus.
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- PrimaryPurpose: Treatment
Brief 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
Intervention / Treatment
- Device: Transcorneal electrical stimulation (TES) with the OkuStim 2 System
Primary Outcome Measures
-
Safety of TES therapy in GA
(From enrolment until the end of the study for the individual participant at 52 weeks)
Determined by the nature and number of device-related adverse events
Countries
Germany
Locations and Investigators
- Department of Ophthalmology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (Recruiting)
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Department of Ophthalmology, Ludwig-Maximilians-University Munich, München, Germany (Recruiting)
- Claudia S. Priglinger, Prof. Dr. (Principal Investigator)
-
Department of Ophthalmology, Klinikum Stuttgart, Stuttgart, Germany (Recruiting)
- Florian Gekeler, Prof. Dr. (Principal Investigator)
- Centre for Ophthalmology, University Hospital Tuebingen, Tübingen, Germany (Recruiting)
-
Department of Ophthalmology, University Hospital Ulm, Ulm, Germany (Not yet recruiting)
- Armin Wolf, Prof. Dr. (Principal Investigator)
Study Officials
- Florian Gekeler, Prof. Dr. (Principal Investigator) — Department of Ophthalmology, Klinikum Stuttgart, Germany