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

Geographic atrophy (GA) is a progressive eye disease that causes the degeneration of theretinal cells, particularly in the macula, leading to vision loss. Currently, there is noapproved therapy specifically for GA in Europe.The aim of this pilot study is to evaluate the safety and potential efficacy of thetreatment of visual field defects in patients with GA using transcorneal electricalstimulation (TES) with the OkuStim 2 System. One of the main mechanisms for the loss ofretinal cells in GA is inflammation. It is known from preclinical studies that electricalstimulation of the eye can inhibit inflammation or cellular reactions to inflammatoryprocesses in the retina, trigger neuroprotective mechanisms and promote blood flow in theretina. The multicentric, randomized, double‐masked, sham‐controlled pilot study is basedon the assumption that these mechanisms can maintain the functional integrity of theouter 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) treatmentAfter an initial training phase, participants will apply the therapy at home, once a weekfor 30 minutes each over a duration of 1 year. Only one eye will be treated (study eye).