Actively Recruiting
Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy Under Everyday Conditions - a Multicentric, Randomized, Double-masked, Sham-controlled Pilot Study
Led by Okuvision GmbH · Updated on 2026-05-07
70
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Okuvision GmbH
Lead Sponsor
C
CONVIDIA clinical research GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Geographic atrophy (GA) is a progressive eye disease that damages retinal cells in the macula, leading to vision loss. This pilot study aims to evaluate the safety and potential effectiveness of transcorneal electrical stimulation (TES) therapy using the OkuStim 2 System in patients with GA. Researchers will compare two different electrical stimulation types with a placebo to see if the treatment is safe and can slow disease progression. Participants will be randomly assigned to one of three groups: TES treatment with a rectangular stimulus, TES treatment with a repetitive ramp stimulus, or a placebo group receiving sham stimulation. After initial training, participants will apply the therapy at home once a week for 30 minutes each session over a 12-month period, with only one eye treated. Throughout the study, participants will be monitored with imaging and vision tests at multiple timepoints to assess safety and changes in retinal structure and function. Researchers will also evaluate patient-reported outcomes about daily life impact and the therapy's ease of use at home. The total study duration for each participant is one year, during which safety and effectiveness data will be collected.
CONDITIONS
Brief Title
Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 agree to use effective contraception during the study
You will not qualify if you...
- History or presence of certain eye conditions such as macular edema, abnormal blood vessel growth, retinal detachment, or 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, 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 such as to silver, or heavy smoking
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 12 months
Participants will apply transcorneal electrical stimulation therapy at home once a week for 30 minutes over a duration of 1 year. The therapy involves stimulation of one eye using the OkuStim 2 System with either a rectangular or repetitive ramp stimulus, or a sham treatment.
Weekly visits for treatment application and assessments at 4, 17, 34, and 52 weeks
Trial Site Locations
Total: 5 locations
1
Department of Ophthalmology, University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Not Yet Recruiting
2
Department of Ophthalmology, Ludwig-Maximilians-University Munich
München, Germany, 80336
Actively Recruiting
3
Department of Ophthalmology, Klinikum Stuttgart
Stuttgart, Germany, 70174
Actively Recruiting
4
Centre for Ophthalmology, University Hospital Tuebingen
Tübingen, Germany, 72076
Actively Recruiting
5
Department of Ophthalmology, University Hospital Ulm
Ulm, Germany, 89075
Not Yet Recruiting
Research Team
R
Ruth Schippert, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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