Artificial Retinal Implant Project Grows (2/16/2008)

USC and Second Sight Medical Products Inc., the developer of retinal prostheses for treating blindness, are expanding the clinical trial of an advanced retinal prosthesis into Europe.

This announcement follows the completion of enrollment in the first phase of a U.S. FDA-approved clinical study of the Argus II Retinal Prosthesis System created by Mark Humayun, professor of ophthalmology and biomedical engineering at the Keck School of Medicine of USC, the Doheny Eye Institute and the USC Viterbi School of Engineering. Studies are continuing in Mexico.

"The pioneering efforts of the individuals who participate in this clinical trial will lead to advances for the many people in the world afflicted with blindness," said Humayun, the first physician to perform an Argus II implantation procedure in the United States.

Humayun was the vitreo-retinal surgeon for the first generation 16-electrode, which he implanted in six retinitis pigmentosa 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, and locate and differentiate basic objects in an environment.

The Argus II is the second generation of an electronic retinal implant designed for the treatment of blindness due to retinitis pigmentosa, a group of inherited eye diseases that affect the retina.

The Argus II implant consists of 60 electrodes attached to the retina. The electrodes conduct information acquired from an external camera to the retina, providing a rudimentary form of sight to implanted subjects.

The development of this technology was largely supported by the National Eye Institute of the National Institutes of Health and the Department of Energy's Office of Science Artificial Retina Project, which is helping to advance the implant's design and construction.

The unique resources and expertise at Department of Energy national laboratories - particularly in engineering, microfabrication, material science and microelectronic technologies - are yielding much smaller, higher resolution devices.

"We are pleased that Second Sight, along with our fantastic clinical partners, was able to fully enroll the U.S. trial in a timely manner," said Robert Greenberg, 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."

Ten subjects have been recruited for the Argus II Phase I trial at four leading ophthalmic centers throughout the U.S., including the Doheny Eye Institute at USC, the 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 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).

The three-year Investigational Device Exemption trial is the only long-term study of a retinal prosthesis currently being conducted anywhere in the world.

"We are excited about the progress being made in the development of this artificial retina technology," said Stephen Rose, chief research officer at the Foundation Fighting Blindness.

The foundation supported early preclinical studies of this technology because of its potential for giving vision to people with the most advanced retinal disease, Rose said, and "we are pleased to have helped advance the prosthesis into critical clinical trials."

The project has received extensive U.S. federal funding ranging from the National Institutes of Health/National Eye Institute to the Office of Science at the Department of Energy.

Other sources of funding for the work at the Doheny Eye Institute 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.

Note: This story has been adapted from a news release issued by the University of Southern California

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