VisionCare, Inc. said this week that the FDA approved its investigational device exemption for a new clinical trial in the U.S. evaluating its telescope implant in patients with end-stage macular degeneration.
The Saratoga, Calif.-based company’s implantable miniature telescope, which was developed by Israeli inventor Dr. Isaac Lipshitz, is contraindicated for patients with previous intraocular or corneal surgery of any kind. This new clinical trial will study the effectiveness of the telescope implant in patients who were previously implanted with an intraocular lens.
“The average patient, at least in North America, has their cataract surgery done between the ages of 68 and 72,” VisionCare president & CEO Blake Michaels said in a conversation with MassDevice.com. By the time the patient’s disease has progressed to the point of end-stage macular degeneration, they’ve most likely had cataract surgery and don’t qualify for the telescope implant because of the device’s contraindication, Michaels told us. “So it’s very frustrating for ophthalmologists and other vision professionals to see certain patients who would be perfect for the telescope but they’ve had cataract surgery in both eyes because they’re 78 years old and they have to tell them, ‘Sorry, we can’t operate on you.'”
The implant, which is smaller than a pea, is “an actual, Galilean telescope,” Michaels explained. It is implanted in 1 eye in an outpatient surgical procedure. The device enlarges images over a wide area of the retina to improve vision, while the non-operated eye provides peripheral vision.
VisionCare was approved to enroll 40 patients initially and collect 6 months of data, at which time the company can enroll another 10 patients. Michaels said the goal of the study is to demonstrate that the implant is safe and effective in this patient population and to move on to a pivotal trial, with the eventual goal of full approval for the indication.
The company has inked 1 contract with an undisclosed site and is actively looking for other sites within the U.S. to conduct the trial.
The telescope implant has won premarket approval from the FDA, the CE Mark in the European Union, and Health Canada listing. The implantable telescope is the only FDA approved surgical device for end-stage macular degeneration, according to VisionCare.