Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy

NCT07531927 | Recruiting

• 1 other identifier: TES-GAP
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration

Keywords

TES; TcES; OkuStim; OkuStim 2; Okuvision; Electrical Stimulation; Transcorneal Electrical Stimulation; Geographic Atrophy; AMD

Outcome Measures

Primary Outcomes (1)

• Safety of TES therapy in GA

  Determined by the nature and number of device-related adverse events

  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

  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

  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

  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

  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

  At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline

Other Outcomes (1)

• Effects of TES therapy with two different stimulus waveforms on functional changes in the GA border zone, depending on position of the microperimetry stimulus points relative to the foveal center

  At 12 months and at timepoints in between (17 and 34 weeks after the baseline-visit) compared to baseline

Study Arms (3)

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.

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.

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

Device: Transcorneal electrical stimulation (TES) with the OkuStim 2 System

Interventions

Transcorneal electrical stimulation (TES) with the OkuStim 2 System DEVICE

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.

TES-treatment with a rectangular stimulus; TES-treatment with a repetitive ramp stimulus

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to understand the study and provide informed consent
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Okuvision GmbH: lead
• CONVIDIA clinical research GmbH: collaborator
• Nubilaria Srl: collaborator
• TentaConsult Pharma & Med GmbH: collaborator
• Department of Ophthalmology, University Hospital Ulm, Germany: collaborator
• Department of Ophthalmology, Klinikum Stuttgart, Germany: collaborator
• Centre for Ophthalmology, University Hospital Tuebingen, Germany: collaborator
• Department of Ophthalmology, University Medical Center Hamburg-Eppendorf, Germany: collaborator
• Department of Ophthalmology, Ludwig-Maximilians-University Munich, Germany: collaborator
• Steinbeis-Forschungszentrum, GRADE Reading Center: collaborator
• Clinical Study Core Unit SZB, Studienzentrum Bonn, University Hospital Bonn, Germany: collaborator

Study Sites (5)

Department of Ophthalmology, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

NOT YET RECRUITING

Department of Ophthalmology, Ludwig-Maximilians-University Munich

München, 80336, Germany

NOT YET RECRUITING

Department of Ophthalmology, Klinikum Stuttgart

Stuttgart, 70174, Germany

NOT YET RECRUITING

Centre for Ophthalmology, University Hospital Tuebingen

Tübingen, 72076, Germany

RECRUITING

Department of Ophthalmology, University Hospital Ulm

Ulm, 89075, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Florian Gekeler, Prof. Dr.

  Department of Ophthalmology, Klinikum Stuttgart, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth Schippert, PhD

CONTACT

+49 7121 15935; studies@okuvision.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient is masked to the treatment group he or she has been assigned to. The programming of the stimulation parameters on the OkuStim 2 is carried out by unmasked members of the study team as it is impossible to program the OkuStim 2 without knowing the assignment of the patient to the study group. Examinations relating to the primary, secondary or exploratory endpoints are carried out only by masked team members.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients are assigned 1:1:1 to one of three different groups: Sham group (sham treatment), biphasic rectangular pulses, or repetitive ramp stimulus.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)