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Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy Under Everyday Conditions - a Multicentric, Randomized, Double-masked, Sham-controlled Pilot Study

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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

• Eye conditions must allow for good-quality images and reliable measurements

• Must have a minimum level of visual acuity

• Women of childbearing potential must have a negative pregnancy test, and must agree to use effective contraception during the study (women who are postmenopausal or surgically sterile are not subject to pregnancy-related requirements)

Locations
Other Locations
Germany
Department of Ophthalmology, University Medical Center Hamburg-Eppendorf
NOT_YET_RECRUITING
Hamburg
Department of Ophthalmology, Ludwig-Maximilians-University Munich
NOT_YET_RECRUITING
München
Department of Ophthalmology, Klinikum Stuttgart
NOT_YET_RECRUITING
Stuttgart
Centre for Ophthalmology, University Hospital Tuebingen
RECRUITING
Tübingen
Department of Ophthalmology, University Hospital Ulm
NOT_YET_RECRUITING
Ulm
Contact Information
Primary
Ruth Schippert, PhD
studies@okuvision.de
+49 7121 15935
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2028-06
Participants
Target number of participants: 70
Treatments
Experimental: TES-treatment with a rectangular stimulus
A ramp is applied in the beginning of the stimulation to avoid that the patient is startled by the onset of stimulation: 0µA to therapy amplitude, ramping up in 30 seconds. The therapy amplitude is then maintained for 30 minutes. The stimulation parameters are: symmetric biphasic rectangular pulse (anodic at first) with a frequency of 20 Hz and a pulse duration of 10ms (5ms each phase). Stimulation will be performed once per week, for 30 minutes, for 12 months.
Experimental: TES-treatment with a repetitive ramp stimulus
A ramp is applied in the beginning of the stimulation to avoid that the patient is startled by the onset of stimulation: 0µA to therapy amplitude, ramping up in 30 seconds. The therapy amplitude is then maintained for 30 minutes. The stimulation parameters are: ramp-down sawtooth current pulses (anodic first) with a frequency of 20 Hz. Stimulation will be performed once per week, for 30 minutes, for 12 months.
Sham_comparator: Sham group
The stimulation in the sham-group will be carried out with 0µA. Sham-stimulation will be performed once per week, for 30 minutes, for 12 months
Related Therapeutic Areas
Geographic Atrophy
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: Okuvision GmbH
Collaborators: Steinbeis-Forschungszentrum, GRADE Reading Center, Department of Ophthalmology, Klinikum Stuttgart, Germany, Clinical Study Core Unit SZB, Studienzentrum Bonn, University Hospital Bonn, Germany, Centre for Ophthalmology, University Hospital Tuebingen, Germany, TentaConsult Pharma & Med GmbH, Nubilaria Srl, Department of Ophthalmology, University Medical Center Hamburg-Eppendorf, Germany, Department of Ophthalmology, University Hospital Ulm, Germany, Department of Ophthalmology, Ludwig-Maximilians-University Munich, Germany, CONVIDIA clinical research GmbH

This content was sourced from clinicaltrials.gov

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