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Mini-telescope for severe AMD begins phase 2/3 trial
SARATOGA, Calif. — An implantable telescope for patients with low vision due to retinal conditions will be evaluated in a phase 2/3 trial, according to the device’s manufacturer
The Implantable Miniature Telescope is a micro-sized precision telescope that can be implanted in the eye in an outpatient procedure, according to maker VisionCare Ophthalmic Technologies. The telescope provides magnification of 3X or 2.2X, depending upon model.
The phase 2/3 trial will determine the safety and efficacy of the device in patients with moderate to severe bilateral central vision impairment due to age-related macular degeneration or Stargardt’s macular dystrophy.
Fourteen patients were enrolled in the company’s phase 1 trial. One year after implantation, most patients gained 3 or more lines of distance or near visual acuity. Transient inflammation was the most common side effect.
The phase 2/3 trial will enroll about 200 patients at up to 30 ophthalmic centers in the United States.