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Retina Implant AG gibt Veröffentlichung der Studienergebnisse zu ihrem Alpha IMS-Implantat in Royal Society B bekannt

- Erstpublikation der zweiten klinischen Studie des Retina-Implantats am Menschen zur Untersuchung der Möglichkeit, die Sehfunktion von Patienten mit Retinitis pigmentosa mithilfe eines Funk-Mikrochips wiederherzustellen

REUTLINGEN, Deutschland, 20. Februar 2013 /PRNewswire/ -- Die Retina Implant AG, der führende Entwickler subretinaler Implantate für Menschen, die an Retinitis pigmentosa (RP) erblindet sind, gab heute bekannt, dass Teilergebnisse ihrer multizentrischen Studie heute in der von Experten begutachteten Fachzeitschrift Proceedings of the Royal Society B erschienen sind. Während des drei- bis neunmonatigen Beobachtungszeitraums der Untersuchung wurde festgestellt, dass die Mehrzahl der insgesamt neun deutschen Patienten, denen im Zuge der ersten Stufe der zweiten klinischen Studie am Menschen des Unternehmens ein subretinaler Mikrochip implantiert wurde, ihre Sehfunktion wiedererlangt hat. Ferner übertraf die Sehschärfe von zwei der neun Patienten die Sehschärfe der Patienten aus der ersten klinischen Studie, die das Unternehmen am Menschen durchgeführt hat.

(Foto: http://photos.prnewswire.com/prnh/20130219/NE60796-a )
(Foto: http://photos.prnewswire.com/prnh/20130219/NE60796-b )
(Logo: http://photos.prnewswire.com/prnh/20130201/NE51162LOGO )

Die Studie mit dem Titel „Artificial Vision with Wirelessly Powered Subretinal Electronic Implant Alpha IMS" wurde von Forschern der Universitäts-Augenklinik Tübingen (Deutschland) geleitet, darunter Professor Eberhart Zrenner und Dr. med. Katarina Stingl. Patienten wurde der subretinale Funk-Mikrochip Alpha IMS mit einer Abmessung von 3 x 3 mm2 und einer Auflösung von 1500 Pixeln der Retina Implant AG implantiert. Dabei waren sie in der Lage, sich dem erhaltenen Stimulationsniveau anzupassen und Objekte in unterschiedlicher Distanz wahrzunehmen. Von den insgesamt neun Patienten, die im Rahmen der Studie beobachtet wurden, waren drei Patienten spontan zum Lesen von Buchstaben fähig. Während der Beobachtung inner- und außerhalb des Labors berichteten Patienten auch davon, Gesichter erkennen, Objekte wie Telefone unterscheiden und Türschilder lesen zu können.

„Die Ergebnisse unserer ersten klinischen Studie am Menschen haben unsere Erwartungen übertroffen und die Ergebnisse der zweiten Studie am Menschen stimmen uns noch zuversichtlicher", so Professor Dr. med. Eberhart Zrenner, Leiter der klinischen Prüfung am Institut für ophthalmologische Forschung der Universitäts-Augenklinik Tübingen (Deutschland). „Als Fachärzte suchen wir unentwegt nach den besten Behandlungsoptionen für unsere hilfebedürftigsten Patienten, wozu ganz bestimmt auch jene zählen, die an Retinitis pigmentosa im fortgeschrittenen Stadium leiden. Diese Untersuchung bietet zusätzliche Hinweise darauf, dass unser subretinales Implantationsverfahren einigen Patienten mit Netzhautdegeneration dabei helfen kann, ihre Sehfunktion wiederzuerlangen – ohne dass hierfür äußerlich erkennbare Geräte erforderlich wären."

„Die Fortsetzung unserer Studie und die Publikation der Ergebnisse aus dieser Stufe ist der nächste Meilenstein unseres Vorhabens, die CE-Kennzeichnung zu erhalten und in völliger Dunkelheit lebenden RP-Patienten eine Behandlungsoption zu bieten", so Walter-G. Wrobel, Vorstandsvorsitzender und CEO der Retina Implant AG. „Mit ihrer Bereitschaft, an dieser richtungsweisenden Studie teilzunehmen, bewegen uns die 36 Patienten, denen wir bisher Implantate eingesetzt haben, immer wieder zutiefst."

Die erste klinische Studie des Unternehmens begann im Jahr 2005 in Deutschland, als 11 an Retinitis pigmentosa erkrankten Patienten subretinale Mikrochips im Makulabereich unter der Netzhaut implantiert wurden. Die Ergebnisse der ersten Studie wurden im November 2010 in Proceedings of the Royal Society B veröffentlicht. Abschließend wurde dabei festgestellt, dass durch Implantation des Mikrochips von Retina Implant eine nützliche Sehfähigkeit bei an Retinitis pigmentosa erblindeten Patienten erfolgreich wiederhergestellt werden konnte. Die zweite klinische Studie mit einem drahtlosen Endgerät, welches Patienten die Möglichkeit bietet, das Implantat sowohl zu Hause als auch im Freien zu nutzen, begann im Mai 2010 in Tübingen (Deutschland). Mittlerweile hat die multizentrische Phase der Studie mit Implantaten begonnen, die in Hongkong und dem Vereinigten Königreich stattfindet.

„Als eine führende und maßgebliche Patientenorganisation im Vereinigten Königreich haben wir die Forschungsmaßnahmen der Retina Implant AG mit großem Interesse verfolgt", so David Head, CEO von RP Fighting Blindness. „Die heute veröffentlichten Ergebnisse sind sehr vielversprechend, sodass die Sehfunktion von Patienten mit Retinitis pigmentosa im fortgeschrittenen Stadium eines Tages wiederhergestellt werden könnte."

Informationen zu Retinitis pigmentosa
Retinitis pigmentosa (RP) zählt zu den häufigsten Formen vererbter Netzhautdegenerationen, von der 1,5 Millionen Menschen weltweit betroffen sind. RP ist eine fortschreitende Erkrankung, die sich mit der Zeit verschlimmert und im Erwachsenenalter typischerweise zu schwerer Sehbehinderung führt. Retina-Implantate bieten RP-Patienten neue Hoffnung auf die Wiederherstellung ihres Sehvermögens.

Informationen zur Retina Implant AG
Die Retina Implant AG ist der führende Entwickler subretinaler Implantate für sehbehinderte und erblindete Patienten. Nach umfangreichen Forschungsarbeiten in Zusammenarbeit mit deutschen Universitätskliniken und Instituten sowie einer intensiven Förderung durch das Bundesministerium für Bildung und Forschung ab 1996 wurde die Retina Implant AG im Jahr 2003 von Dr. Eberhart Zrenner und seinen Kollegen unter Einbeziehung privater Investoren mit dem Ziel gegründet, das erste voll funktionsfähige, elektronische Retina-Implantat zu entwickeln, mit dessen Hilfe das Sehvermögen erblindeter Menschen wiederhergestellt werden kann. Seit 2005 führt das Unternehmen Implantationsverfahren an menschlichen Patienten durch und startete 2010 eine zweite klinische Versuchsreihe. Nähere Informationen erhalten Sie auf: http://www.retinaimplant.de/.

Informationen zu Royal Society Publishing
Die Royal Society ist eine sich selbst verwaltende Verbindung, der viele der angesehensten Forscher aus den Bereichen Wissenschaft, Ingenieurswesen und Medizin angehören. Das grundsätzliche Ziel des Verbandes besteht seit seiner Gründung im Jahre 1660 darin, wissenschaftliche Spitzenleistungen zu würdigen, voranzutreiben und zu unterstützen – und die Entwicklung sowie den Nutzen der Wissenschaft zum Wohle der Menschheit gezielt zu fördern.

Die strategischen Prioritäten des Verbandes unterstreichen sein Bekenntnis zu höchster wissenschaftlicher Qualität, auf Neugierde beruhender Forschung sowie zur Entwicklung und Nutzung von Wissenschaft zum Wohle der Gesellschaft. Diese Prioritäten sind:
1. Förderung der Wissenschaft und ihrer Vorteile
2. Würdigung exzellenter wissenschaftlicher Leistungen
3. Unterstützung herausragender wissenschaftlicher Leistungen
4. Wissenschaftliche Beratung für die Politik
5. Pflege der internationalen und globalen Zusammenarbeit
6. Bildung und öffentliches Engagement

Besuchen Sie http://royalsociety.org/ für nähere Informationen. Folgen Sie der Royal Society auf Twitter http://twitter.com/royalsociety oder auf Facebook http://www.facebook.com/theroyalsociety.

Schwartz MSL:

Retina Implant AG:

Kirsten Fallon/Charlotte Webber

Walter-G. Wrobel

Anfragen USA: 781-684-0770

+ 49 7121 36403-111

Anfragen EU/Vereinigtes Königreich: +44 (0)7949 872296

[email protected]  

[email protected]  

 

 


 

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