Second Sight doubles patient enrollment for retinal implant study
Second Sight Medical Products Inc. announced that the FDA has granted approval for up to 20 people who are blind or who have severely impaired vision due to retinitis pigmentosa to participate in a feasibility study for its retinal implant (Argus II Retinal Implant) in the United States. Ten RP volunteers are participating in the U.S. study and an additional 12 RP volunteers are participating in similar studies throughout Europe and Mexico.
Fort Lauderdale, FL-Second Sight Medical Products Inc. announced that the FDA has granted approval for up to 20 people who are blind or who have severely impaired vision due to retinitis pigmentosa to participate in a feasibility study for its retinal implant (Argus II Retinal Implant) in the United States. Ten RP volunteers are participating in the U.S. study and an additional 12 RP volunteers are participating in similar studies throughout Europe and Mexico.
The retinal implant is a three-part system designed to transmit information about the physical environment directly to an individual’s retina-bypassing the photoreceptors that have been damaged due to RP. The device consists of a 60-electrode grid that is implanted surgically and attached to the retina. The electrodes transmit information acquired from an external video camera that is mounted on a pair of eyeglasses worn by study volunteers. The implant has been designed to last for several years, but can be safely removed if necessary, according to the company.
“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, MD, PhD, 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 European and U.S. market approvals.”
Six U.S. ophthalmic centers are participating in the study and actively recruiting study volunteers. These centers include the Columbia University Medical Center/Lighthouse International, New York; Doheny Eye Institute, University of Southern California, Los Angeles; Retina Foundation of the Southwest, Dallas; Scheie Eye Institute/Wills Eye Hospital, Philadelphia; University of California, San Francisco; and Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore.
Four major European centers are participating and actively enrolling volunteers in the study. These centers include Central Manchester University Hospital in Manchester, England; Le Centre Hospitalier National d’Ophtalmologie des Quinze-Vingts, Paris; Moorfields Eye Hospital, London; and Service d’Ophtalmologie, Hôpital Cantonal Universitaire de Genève, Geneva, Switzerland. The study also is being conducted at Centro de Retina Medica y Quirurgica SC; Centro Medico Puerta de Hierro CUCS; and Universidad de Guadalajara in Guadalajara, Mexico.