The G-BA (Federal Joint Committee) has prepared the path for a transcorneal electrical stimulation (TES) trial study for retinitis pigmentosa. Following a successful application for a trial by the manufacturer of an appropriate stimulation device and its agreement to cover the costs of collecting and evaluating the data, the G-BA decided on a relevant guideline on 20 July 2017. This defines the key points of the planned study such as target population, control intervention, study type and period. The trial will be conducted and evaluated by an independent scientific institution, which will be chosen following a public invitation to tender. The DLR (German Aerospace Centre) will help the G-BA select the successful bidder and subsequently oversee the trial. It was chosen by the G-BA for this purpose following a Europe-wide tendering process.
Retinitis pigmentosa is a form of retinal degeneration caused by hereditary factors or spontaneous mutation and irreversibly destroys the photoreceptors. In most cases, the disease results in blindness. The aim of TES is to use electrical stimulation of the retina by a corneal electrode to slow down the destruction of the sensory cells, thereby maintaining patients’ vision for longer.