"We hope these published results will lead to a new treatment option for patients with end-stage AMD," commented Stephen S. Lane, M.D., the trial's medical monitor who is an adjunct professor of ophthalmology, University of Minnesota, and in private practice at Associated Eye Care, Stillwater, MN. "Across the 28 centers in the study, we were able to provide a novel approach for patients whom we have not had any solutions to improve visual acuity in a functional way."
End-Stage AMD occurs when the macula in each eye is irreversibly degenerated and no longer provides detailed central vision required for common everyday activities such as reading, recognizing people and facial expressions, or watching television. End-Stage AMD is characterized by central scotomas, or blind spots, in both eyes that cause images in the central visual field to be unrecognizable or not visible at all. AMD is the leading cause of irreversible blindness in the United States and other developed countries.
Highlights from the AJO publication on the prospective, multicenter IMT002 study are summarized below.
Efficacy:
-- 60% of telescope-implanted study eyes gained 3 lines (15 letters) or more of visual acuity (VA) at 2 years after implantation versus 10% of fellow eye controls (p<0.0001)
-- Study eyes receiving the 3X model telescope prosthesis showed an average VA improvement of 3.6 lines at 2 years compared to 0.5 lines in fellow eye controls (p<0.0001)
-- Median VA improvement was over 3 lines better in telescope-implanted eyes versus corresponding fellow eyes that underwent cataract surgery and intraocular lens implantation (p<0.0002)
Safety:
-- Loss of 3 lines (15 letters) or more of VA occurred in 0.6% of telescope-implanted eyes versus 7.5% of fellow eye controls (p=0.0013)
-- Corneal endothelial cell loss was 27% two y
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