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

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

Overview

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).

Interventions

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

Primary outcome measures

• Safety of TES therapy in GA [Time frame: From enrolment until the end of the study for the individual participant at 52 weeks]

Secondary outcome measures (7)

• 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Germany · 5 centers

• Department of Ophthalmology, University Medical Center Hamburg-Eppendorf — Hamburg
• Department of Ophthalmology, Ludwig-Maximilians-University Munich — München
• Department of Ophthalmology, Klinikum Stuttgart — Stuttgart
• Centre for Ophthalmology, University Hospital Tuebingen — Tübingen
• Department of Ophthalmology, University Hospital Ulm — Ulm

Identifiers

NCT: NCT07531927 · TES-GAP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗