USC and Second Sight Medical Products Inc, leading developers of retinal prostheses for treating blindness, announced today that they have completed enrollment of the first phase of a U.S .FDA approved clinical study of the Argus II Retinal Prosthesis System. They also announced that enrollment at key European sites is underway as studies continue in Mexico.
"We are pleased that Second Sight, along with our fantastic clinical partners, was able to fully enroll the US trial in a timely manner," said Robert Greenberg, MD, PhD, President and CEO of Second Sight, and a leader in the field of retinal prostheses for more than 15 years.
"Although it is too early to comment on the clinical data, each device continues to function as expected, and all participants are using their systems at home daily."
The Argus II is the second generation of an electronic retinal implant designed for the treatment of blindness due to Retinitis Pigmentosa (RP), a group of inherited eye diseases that affect the retina. The Argus II implant consists of an array of 60 electrodes that are attached to the retina. These electrodes conduct information acquired from an external camera to the retina to provide a rudimentary form of sight to implanted subjects.
The development of this technology was largely supported by the National Eye Institute (NEI) of the National Institutes of Health (NIH), and the Department of Energy's Office of Science (DOE) Artificial Retina Project, which is helping to advance the implant's design and construction. The unique resources and expertise at DOE national laboratories--particularly in engineering, microfabrication, material science, and microelectronic technologies--are enabling the development of much smaller, higher resolution devices.
Ten subjects were recruited for the Phase I trial at four leading ophthalmic centers throughout the US, including the Doheny Eye Institute at the University of Southern California (USC), Wilmer Eye Institute at Johns Hopkins University (Baltimore), the University of California at San Francisco, and the Retina Foundation of the Southwest (Dallas). Second Sight will be seeking expansion of the U.S. trial to include other trial sites located in New York (Columbia University Medical Center and Lighthouse International), Philadelphia (Scheie Eye Institute and Wills Eye Hospital) and Atlanta (Emory University and Atlanta V.A. Rehab R&D Center). This three-year Investigational Device Exemption (IDE) trial is the only long-term study of a retinal prosthesis currently being conducted anywhere in the world.
Internationally, the Argus II study began in Mexico in the fall of 2006 at Centro de Retina Medica y Quirurgica, SC, Centro Medico Puerta de Hierro, CUCS, Universidad de Guadalajara (Guadalajara, Jal.). More recently, enrollment has just begun at two European sites, including Service d'Ophtalmologie, Hôpital Cantonal, Universitaire de Genève (Geneva, Switzerland) and Le Centre Hospitalier National D'Ophtalmologie Des Quinze-Vingts (Paris, France). A third study site at Moorfields Eye Hospital in London has recently received government approval and is expected to begin enrollment shortly.
"The pioneering efforts of the individuals that participate in this clinical trial will lead to advances for the many people in the world afflicted with blindness," said Mark Humayun, MD, PhD, Professor of Ophthalmology, Biomedical Engineering, and Cellular and Neurobiology at the Doheny Eye Institute, Keck School of Medicine of USC, and Viterbi School of Engineering and the first physician to perform an Argus II implantation procedure in the US.
Dr. Humayun was the vitreo-retinal surgeon for the first generation 16-electrode (Argus™ 16), which he implanted in six RP subjects between 2002 and 2004. The study demonstrated the ability of participants to detect when lights are on or off, describe an object's motion, count discrete items, as well as locate and differentiate basic objects in an environment.
"We are excited about the progress being made in the development of this artificial retina technology," says Stephen Rose, PhD, Chief Research Officer, Foundation Fighting Blindness (FFB).
"FFB supported early preclinical studies of this technology, because of its great potential for giving vision to people with the most advanced retinal disease and we are pleased to have helped advance the prosthesis into critical clinical trials."
Second Sight and USC have received extensive U.S. federal support in developing this new technology and are grateful for the forward thinking of the National Institutes of Health/National Eye Institute and the Office of Science at the Department of Energy in supporting significant aspects of this work.
Other sources of funding for the work at the Doheny Eye Institute at USC include the National Science Foundation, which supported the development of the Argus II integrated circuit, the W.M.Keck Foundation, Research to Prevent Blindness and the Albaugh Family Trust.
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