Geographic Atrophy Secondary to Age-related Macular Degeneration
Investigational drug(s) / intervention(s)
Transcorneal electrical stimulation (TES) with the OkuStim 2 SystemTranscorneal electrical stimulation (TES) with the OkuStim 2 System
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.
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
Study 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
Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
Inclusion criteria:
* 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)
Exclusion criteria:
* 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
* Planned eye surgery during the study period
* Recent treatment with investigational drugs for geographic atrophy
* Presence of active medical implants
* Serious or uncontrolled systemic diseases, history of epilepsy or poor general health or conditions affecting the ability to follow study procedures
* Participation in another clinical study recently or at the same time
* Breastfeeding, relevant allergies (e.g. to silver), or heavy smoking
Primary outcome measure(s)
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
Trial sites (5)
Facility
City
Region
Status
Department of Ophthalmology, University Medical Center Hamburg-Eppendorf
Hamburg
Germany
Recruiting
Department of Ophthalmology, Ludwig-Maximilians-University Munich
München
Germany
Recruiting
Department of Ophthalmology, Klinikum Stuttgart
Stuttgart
Germany
Recruiting
Centre for Ophthalmology, University Hospital Tuebingen
Tübingen
Germany
Recruiting
Department of Ophthalmology, University Hospital Ulm
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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