NCT07531927

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

Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy Under Everyday Conditions - a Multicentric, Randomized, Double-masked, Sham-controlled Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Okuvision GmbH · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Geographic Atrophy Secondary to Age-related Macular Degeneration

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

5 sites across 1 country: Germany