Okuvision GmbH Initiates Multi-Center, Post-Market Study
100 Patients across Europe to Receive Transcorneal Electrical Stimulation (TES)
By Okuvision GmbH
Published: Thursday, Nov. 8, 2012 - 6:12 am
REUTLINGEN, Germany, Nov. 8, 2012 -- /PRNewswire/ -- Okuvision GmbH, an innovator in the field of transcorneal electrical stimulation (TES) therapy for early and intermediate stage retinitis pigmentosa (RP) patients, today announced the start of a multi-center, post-market study for the company's CE marked OkuStim® treatment. OkuStim represents an advance in the treatment of RP, providing patients with a clinical option that has been shown to delay the progress of RP-related blindness. The new, post-market study, called TESOLA, is currently underway and enrolling patients at six sites in Germany, Norway and Denmark. Four additional sites in Germany and the UK are working with their internal regulatory boards to gain approval to become active study sites within the coming weeks.
"Medical technology is progressing at an ever-increasing pace, and with developments such as OkuStim TES, patients with RP are gaining new hope for delaying and possibly preventing blindness from the disease," said Professor Florian Gekeler, lead clinical trial investigator and consultant at the Centre for Ophthalmology of the University of Tuebingen, Germany. "Patients involved in the pilot study saw a significant increase in their field of vision after receiving 150 percent of their perceived threshold of stimulation for six weeks. Our team looks forward to determining the impact of long-term use of this level of stimulation."
The TESOLA study will accrue 100 patients across all of the centers who will receive 150 percent of the perceived threshold level of OkuStim therapy for 30 minutes once a week over a six-month period. After the physicians determine each individual patient's threshold, patients will administer the weekly TES therapy in the comfort of their homes. Patients can also choose to undergo the therapy in the clinic or continue its use at home under the close guidance of a doctor associated with one of the participating clinics. The TESOLA study is the third human clinical study of OkuStim TES, and the first where all participants will receive the same level of stimulation. Patients involved in the company's pilot study, as well as the 58 patients involved in the EST2 study currently underway in Tuebingen, Germany, were broken into three groups receiving various levels of TES therapy.
OkuStim received CE mark approval in December 2011 for use as a treatment to help delay the progression of RP. The device consists of a frame worn on the patient's head and a hand-held stimulation controller that works by sending small amounts of current to stimulate the retina. Results of Okuvision's pilot study were published in April 2011 in Investigative Ophthalmology and Visual Science and showed that patients receiving 150 percent stimulation showed a 20 percent statistically significant improvement in their field of vision.
"Okuvision's pilot study demonstrated that the intended use of OkuStim TES to counter the adverse effects of the progression of RP in patients works," said Reinhard Rubow, chief executive officer, Okuvision GmbH. "In order to expand the body of scientific knowledge on TES and the OkuStim technology, we are investing in these post-market studies to provide physicians with a better understanding of the optimal level of stimulation as well as the duration of time patients should receive OkuStim treatment to yield the best results."
The eye hospitals currently participating in the TESOLA study include: Centre for Ophthalmology, University of Tuebingen, Germany; Universitats-Augenklinik Regensburg, Germany; Zentrum fur seltene Netzhauterkrankungen, Siegburg, Germany; Klinikum Rechts der Isar, Munich, Germany; Glostrup Hospital and Kennedy Center - National Eye Clinic, University of Copenhagen, Denmark; and Department of Ophthalmology, Oslo University Hospital, Norway.
The following additional sites plan to join the TESOLA study upon receiving internal review board approval: an additional eye hospital in Berlin, Germany; Universitats-Augenklinik Bonn, Germany; Moorefields Eye Hospital NHS Foundation Trust, London, UK; and Oxford Eye Hospital, NHS Foundation Trust, Oxford, UK.
About Okuvision GmbH Founded by the leaders of Retina Implant AG in 2007, Okuvision GmbH is an innovator in the field of transcorneal electrical stimulation (TES) for patients with early and intermediate stage retinitis pigmentosa. Building on the lessons learned through the use of Retina Implant AG's subretinal implant technology, Okuvision was founded with the goal of testing and developing a treatment option aimed at delaying the effects of retinitis pigmentosa. Okuvision's first study began in 2007 and treated 24 patients over a period of six weeks. To learn more, please visit: www.okuvision.de/en.
