Retinitis Pigmentosa (RP) is a progressive degeneration of photoreceptor cells in the retina leading to severe vision impairment and, in most cases, to blindness. Transcorneal electrical stimulation (TES) uses electrical stimulation of the retina by a corneal electrode with the aim to slow down the destruction of the sensory cells and thereby preserving the visual performance of the patients for a longer time.
The Federal Joint Committee (G-BA) sees a potential in TES as a treatment alternative for patients with retinitis pigmentosa. However, the evidence is currently insufficient to show a benefit of the method. G-BA has therefore approved the conduction of a trial study according to §137e of the Social Code Book V. This paragraph regulates the generation of evidence of potential treatment methods troughs the co-funded trial to provide a decision base for inclusion into the statutory health benefit catalogue.
The trial procedure was initiated by a successful application submitted by the manufacturer (Okuvision). On July 20th 2017, the G-BA decided on a guideline defining the key points of the planned trial. The study will be designed as a double-blinded randomized controlled trial with placebo treatment as a control group. Data collection will take place in multiple centers in Germany. The primary endpoint measured in the study is a clinically relevant change of the range of vision; secondary endpoints are visual acuity, color perception, contrast perception, health-related quality of life and undesirable events.
The study will be conducted and evaluated by an independent research institute chosen through a public invitation to tender. The manufacturer will contribute to the costs for the conduction and evaluation of the trial. Once results from the trial are available, the G-BA will evaluate the evidence and decide about the inclusion of TES into the health benefits catalogue. In case of a positive decision, the method is categorized as reimbursable both for in- and out-patient settings.
The full guideline of the trial in German is available here.
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