Transcorneal electrical stimulation to slow geographic atrophy
Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy Under Everyday Conditions - a Multicentric, Randomized, Double-masked, Sham-controlled Pilot Study
This study will see if weekly at-home transcorneal electrical stimulation with the OkuStim 2 device can slow vision loss in people aged 60 and older with geographic atrophy from age-related macular degeneration.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Okuvision GmbH Industry-sponsored |
| Locations | 5 sites (Hamburg and 4 other locations) |
| Trial ID | NCT07531927 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, double-masked, sham-controlled pilot compares two types of transcorneal electrical stimulation (rectangular vs repetitive ramp) against a placebo over one year. Participants are randomly assigned 1:1:1, treat one eye, receive training, and then apply a 30-minute session at home once a week for 12 months. The trial focuses on safety and on whether TES can slow progression of visual field loss by reducing retinal inflammation, promoting neuroprotection, and improving retinal blood flow—mechanisms supported by preclinical work. Clinical outcomes and imaging are collected at study visits at participating German ophthalmology centers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 or older with imaging-confirmed geographic atrophy from AMD, lesion size and visual acuity within the study's required ranges, and the ability to use the OkuStim device and attend clinic visits.
Not a fit: Patients with other active retinal diseases, prior major retinal surgery, lesions outside the defined size range, or inability to obtain reliable imaging or use the device likely would not receive benefit from this intervention.
Why it matters
Potential benefit: If successful, the therapy could slow progression of geographic atrophy and help preserve central vision for a longer time.
How similar studies have performed: Preclinical studies and small clinical TES reports have shown safety signals and possible neuroprotective effects, but robust, large-scale evidence of benefit in geographic atrophy is still lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hamburg and 4 other locations
- Department of Ophthalmology, University Medical Center Hamburg-Eppendorf — Hamburg, Germany (Not_yet_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 — Ulm, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Florian Gekeler, Prof. Dr. — Department of Ophthalmology, Klinikum Stuttgart, Germany
- Study coordinator: Ruth Schippert, PhD
- Email: studies@okuvision.de
- Phone: +49 7121 15935
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.