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Second Sight to increase European enrollment for trial of retinal implant
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LAUSANNE, Switzerland — Second Sight Medical Products plans to increase European patient enrollment and is considering establishing additional trial sites for its 3-year feasibility study of the Argus II Retinal Prosthesis System among patients with retinitis pigmentosa, the company announced.
The phase 1 clinical trial, called the Argus II Retinal Implant study, is under way in the United States, Mexico and Europe, where three major centers are now participating, according to a press release from the company.
The Argus II device is a second-generation retinal prosthesis that attaches a 60-electrode grid to the retina. These electrodes are able to transmit information acquired from an external video camera that is mounted on a pair of eyeglasses worn by the implanted subject.
According to preliminary study results for 17 enrolled patients, which were presented at the American Society of Retinal Specialists meeting in October, there were no device failures and few serious adverse events, according to the release.
After an average of 14 months, the most serious adverse event resulted in the removal of an implant with no difficulty or damage to the patient, the release said. Additionally, the first 11 implanted patients were able to locate a door up to 20 feet away and walk to the end of a 20-foot line drawn on the floor.
Second Sight is currently seeking permission from the U.S. Food and Drug Administration to further expand the U.S. arm of the trial, which has enrolled patients in four leading ophthalmic centers to date.
"These first results hold a novel and quite unprecedented promise for blind subjects as well as the physicians and researchers that have the opportunity to participate in this pioneering endeavor," Jose-Alain Sahel, MD, principal investigator and chairman of the department of ophthalmology, Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, said in the release. "We now have a strong incentive for continuing and expanding the efforts in testing this new technology."