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Enrollment complete for phase 1 retinal implant clinical trial
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LOS ANGELES — The University of Southern California and Second Sight Medical Products Inc. have completed enrollment for a phase 1 clinical trial of the Argus II Retinal Prosthesis System, according to a press release from the university. Enrollment has also commenced for clinical trials of the device at two European sites, with a third site expected to begin enrollment shortly, the release said.
The Argus II retinal implant was designed for treating blindness due to retinitis pigmentosa. The device affixes an array of 60 electrodes to the retina, which conduct information acquired by an external camera, providing implanted patients with a rudimentary form of vision, according to the release.
The U.S. phase 1 trial is the only current long-term study of a retinal prosthesis being conducted worldwide, the release said.
The trial is being conducted under a U.S. Food and Drug Administration investigational device exemption and has recruited 10 patients at four centers, with plans to expand the trial to include additional sites, the release said.