Second Sight Recruiting More Participants for U.S. Retinal Prosthesis Study
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Retinal implant offers partially restored vision for people with retinitis pigmentosa *This product now has approval. Click here for an update. Second Sight Medical Products, Inc., developer of the retinal prosthesis known as the Argus II, is seeking 10 additional participants for its feasibility clinical study in the United States. A total of 22 people have already participated in the three-year study, which is underway in the U.S., Europe, and Mexico.
”We are pleased that the FDA has approved our request for increased enrollment of the U.S. cohort of our international clinical trial,” said Robert Greenberg, M.D., Ph.D., president and chief executive officer of Second Sight. ”We expect this data to continue to demonstrate a good safety profile with significant efficacy improvements and to move us one step closer to E.U. and U.S. market approvals.” The Argus II is the second-generation of Second Sight’s retinal prosthesis technology. The device consists of a 60-electrode grid that is surgically implanted on the retina. (The first-generation device has 16 electrodes.) The electrodes transmit information acquired from an external video camera that is mounted on a pair of eyeglasses worn by the user. Investigators hope the 60-electrode device will provide users with better detailed vision than the 16-electrode device. “Second Sight’s artificial prosthesis is providing real hope for restoring some vision to people who have lost all of their eyesight to advanced retinal degenerative diseases,” said Stephen Rose, Ph.D., chief research officer, Foundation Fighting Blindness. “We are very pleased to see expansion of their human studies and advancement of the technology.” The Foundation Fighting Blindness funded early, preclinical studies of the retinal prosthesis. Second Sight is actively recruiting participants for their current studies. For information about participating in the studies, visit www.clinicaltrials.gov and search on “Argus.” Inquiries can also be made by e-mailing
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The Argus II has demonstrated a good safety profile as well as the ability to give some rudimentary vision to people with retinitis pigmentosa who were completely blind or could only perceive light. In a report on the first 11 Argus II study volunteers presented late last year, investigators noted that volunteers were frequently able to locate a door up to 20-feet away and walk to the end of a 20-foot line drawn on the floor. Additional data on the study was be presented at this year’s Association for Research in Vision and Ophthalmology meeting.
