Geographic Atrophy Secondary to Age-related Macular DegenerationTES-GAPNCT07531927
Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy
A study testing Transcorneal electrical stimulation (TES) with the OkuStim 2 System in people with Geographic Atrophy Secondary to Age-related Macular Degeneration, run by Okuvision GmbH at 5 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Geographic Atrophy Secondary to Age-related Macular Degeneration
- What is being tested?
- Transcorneal electrical stimulation (TES) with the OkuStim 2 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 5 sitesGermany
- Study dates
- 5 May 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Germany5 sites, 5 recruiting
- Recruiting
Department of Ophthalmology, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
- Recruiting
Department of Ophthalmology, Ludwig-Maximilians-University Munich
München, 80336
augenklinik.studien@med.uni-muenchen.de
Claudia S. Priglinger, Prof. Dr.
- Recruiting
Department of Ophthalmology, Klinikum Stuttgart
Stuttgart, 70174
Florian Gekeler, Prof. Dr.
- Recruiting
Centre for Ophthalmology, University Hospital Tuebingen
Tübingen, 72076
- Not yet recruiting
Department of Ophthalmology, University Hospital Ulm
Ulm, 89075
studienzentrale.augenklinik@uniklinik-ulm.de
Armin Wolf, Prof. Dr.
About this study
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
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.
Read more
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.
Read the detailed description
Geographic atrophy (GA) is a progressive eye disease that causes the degeneration of the retinal cells, particularly in the macula, leading to vision loss. Currently, there is no approved therapy specifically for GA in Europe.
The aim of this pilot study is to evaluate the safety and potential efficacy of the treatment of visual field defects in patients with GA using transcorneal electrical stimulation (TES) with the OkuStim 2 System. One of the main mechanisms for the loss of retinal cells in GA is inflammation. It is known from preclinical studies that electrical stimulation of the eye can inhibit inflammation or cellular reactions to inflammatory processes in the retina, trigger neuroprotective mechanisms and promote blood flow in the retina. The multicentric, randomized, double-masked, sham-controlled pilot study is based on the assumption that these mechanisms can maintain the functional integrity of the outer zone of the lesion area for longer.
Participants will be randomly assigned 1:1:1 to one of these three groups:
- TES-treatment with a rectangular stimulus
- TES-treatment with a repetitive ramp stimulus
- Placebo (sham) treatment
After an initial training phase, participants will apply the therapy at home, once a week for 30 minutes each over a duration of 1 year. Only one eye will be treated (study eye).
- Being tested
- Transcorneal electrical stimulation (TES) with the OkuStim 2 System
- Keywords
- TES, TcES, OkuStim, OkuStim 2, Okuvision, Electrical Stimulation, Transcorneal Electrical Stimulation, Geographic Atrophy, AMD
- Medical subject headings
- Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcorneal electrical stimulation (TES) with the OkuStim 2 SystemDevice
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 SystemDevice
Sham-stimulation will be performed once per week, for 30 minutes, for 12 months without effective stimulation
| Study group | Role | What they receive |
|---|---|---|
| TES-treatment with a rectangular stimulus | Experimental | 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. Receives: Device: Transcorneal electrical stimulation (TES) with the OkuStim 2 System |
| TES-treatment with a repetitive ramp stimulus | Experimental | 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. Receives: Device: Transcorneal electrical stimulation (TES) with the OkuStim 2 System |
| Sham group | Sham comparator | 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 Receives: Device: Transcorneal electrical stimulation (TES) with the OkuStim 2 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of TES therapy in GA
Determined by the nature and number of device-related adverse events
Measured: From enrolment until the end of the study for the individual participant at 52 weeks
Secondary outcomes (7)
Effects of TES therapy with two different stimulus waveforms on the progression of GA lesion areas
Assessed by fundus autofluorescence (FAF) in combination with optical coherence tomography (OCT)
Measured: At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline
Effects of TES therapy with two different stimulus waveforms on structural changes in retinal layers
Assessed by OCT
Measured: At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline
Effects of TES therapy with two different stimulus waveforms on functional changes in the border zone of GA areas
Assessed by patient-tailored microperimetry (mMAIA)
Measured: At 12 months and at timepoints in between (17 and 34 weeks after the baseline-visit) compared to baseline
Effects of TES therapy with two different stimulus waveforms on visual acuity under normal luminance conditions
Assessed with ETDRS chart
Measured: At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline
Effects of TES therapy with two different stimulus waveforms on visual acuity under low-luminance conditions
Assessed with ETDRS chart and a neutral density filter
Measured: At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline
Effects of TES therapy with two different stimulus waveforms on patient-reported outcomes regarding the impact on daily life
Assessed with the Vision Impairment in Low Luminance (VILL-33) questionnaire
Measured: At 12 months compared to baseline
Effects of TES therapy with two different stimulus waveforms on patient-reported outcome regarding the applicability of the therapy under everyday conditions during home-use
Assessed with a custom-made questionnaire
Measured: At 12 months compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start5 May 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic Atrophy Secondary to Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okuvision GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Responsible party
- Sponsor
- Investigators
- Florian Gekeler, Prof. Dr., Principal investigator, Department of Ophthalmology, Klinikum Stuttgart, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531927
- Sponsor's protocol ID
- TES-GAP
- Acronym
- TES-GAP
- Status last verified
- May 2026
- First submitted
- 27 Mar 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07531927
- Acronym / sponsor ID
- TES-GAP / TES-GAP
- Keywords
- TES, TcES, OkuStim, OkuStim 2, Okuvision, Electrical Stimulation, Transcorneal Electrical Stimulation, Geographic Atrophy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Okuvision GmbHIndustry (pharma, biotech, devices)
- 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
- Study start
- 5 May 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Geographic atrophy (GA) is a progressive eye disease that causes the degeneration of the retinal cells, particularly in the macula, leading to vision loss. Currently, there is no approved therapy specifically for GA in Europe.
The aim of this pilot study is to evaluate the safety and potential efficacy of the treatment of visual field defects in patients with GA using transcorneal electrical stimulation (TES) with the OkuStim 2 System. One of the main mechanisms for the loss of retinal cells in GA is inflammation. It is known from preclinical studies that electrical stimulation of the eye can inhibit inflammation or cellular reactions to inflammatory processes in the retina, trigger neuroprotective mechanisms and promote blood flow in the retina. The multicentric, randomized, double-masked, sham-controlled pilot study is based on the assumption that these mechanisms can maintain the functional integrity of the outer zone of the lesion area for longer.
Participants will be randomly assigned 1:1:1 to one of these three groups:
- TES-treatment with a rectangular stimulus
- TES-treatment with a repetitive ramp stimulus
- Placebo (sham) treatment
After an initial training phase, participants will apply the therapy at home, once a week for 30 minutes each over a duration of 1 year. Only one eye will be treated (study eye).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients are assigned 1:1:1 to one of three different groups: Sham group (sham treatment), biphasic rectangular pulses, or repetitive ramp stimulus.
| Arm | Type | Receives |
|---|---|---|
| TES-treatment with a rectangular stimulus | Experimental | Device: Transcorneal electrical stimulation (TES) with the OkuStim 2 SystemA 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. |
| TES-treatment with a repetitive ramp stimulus | Experimental | Device: Transcorneal electrical stimulation (TES) with the OkuStim 2 SystemA 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 group | Sham comparator | Device: Transcorneal electrical stimulation (TES) with the OkuStim 2 SystemThe 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcorneal electrical stimulation (TES) with the OkuStim 2 SystemIn 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. | Device | TES-treatment with a rectangular stimulus, TES-treatment with a repetitive ramp stimulus |
| Transcorneal electrical stimulation (TES) with the OkuStim 2 SystemSham-stimulation will be performed once per week, for 30 minutes, for 12 months without effective stimulation | Device | Sham group |
Primary outcome
Safety of TES therapy in GA
Time frame: 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
7 secondary outcomes
Effects of TES therapy with two different stimulus waveforms on the progression of GA lesion areas
Time frame: At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline
Effects of TES therapy with two different stimulus waveforms on structural changes in retinal layers
Time frame: At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline
Effects of TES therapy with two different stimulus waveforms on functional changes in the border zone of GA areas
Time frame: At 12 months and at timepoints in between (17 and 34 weeks after the baseline-visit) compared to baseline
Effects of TES therapy with two different stimulus waveforms on visual acuity under normal luminance conditions
Time frame: At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline
Effects of TES therapy with two different stimulus waveforms on visual acuity under low-luminance conditions
Time frame: At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline
Effects of TES therapy with two different stimulus waveforms on patient-reported outcomes regarding the impact on daily life
Time frame: At 12 months compared to baseline
Effects of TES therapy with two different stimulus waveforms on patient-reported outcome regarding the applicability of the therapy under everyday conditions during home-use
Time frame: At 12 months compared to baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florian Gekeler, Prof. Dr. principal investigator
Department of Ophthalmology, Klinikum Stuttgart, Germany
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcorneal electrical stimulation (TES) with the OkuStim 2 System in people with Geographic Atrophy Secondary to Age-related Macular Degeneration, run by Okuvision GmbH at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruth Schippert, PhD (+49 7121 15935 ext. 55, studies@okuvision.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of TES therapy in GA (time frame: From enrolment until the end of the study for the individual participant at 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.