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

ConditionGeographic Atrophy Secondary to Age-related Macular Degeneration

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60+

SponsorOkuvision GmbH

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.
Transcorneal electrical stimulation (TES) with the OkuStim 2 System
Device
Sham-stimulation will be performed once per week, for 30 minutes, for 12 months without effective stimulation

Treatment groups

70 Participants

are divided into 3 treatment groups

Group A: TES-treatment with a rectangular stimulusExperimental treatment 1 intervention

Group B: TES-treatment with a repetitive ramp stimulusExperimental treatment 1 intervention

Group C: Sham groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

Safety of TES therapy in GA

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

Time frame

From enrolment until the end of the study for the individual participant at 52 weeks

Secondary outcomes

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)

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

Assessed by OCT

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

Assessed by patient-tailored microperimetry (mMAIA)

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

Assessed with ETDRS chart

Time frame

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

Other outcomes

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

Assessed by patient-tailored microperimetry (mMAIA)

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Okuvision GmbH

Lead sponsor

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

Universitätsklinikum Hamburg-Eppendorf

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

Source ClinicalTrials.gov

Apply now