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VisionCare Pivotal Study Shows Improved Vision and Quality of Life Outcomes in Patients with Age-Related Macular DegenerationPositive results presented for advanced, untreatable form of macular degeneration Saratoga, CA - October 19, 2005 - VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices for the treatment of age-related macular degeneration (AMD), today announced positive results from the Phase II/III clinical trial of the investigational Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz) in patients with the untreatable, end-stage form of AMD. One-year efficacy data from the prospective, multicenter trial showed patients had a mean improvement of over 3 lines on the ETDRS (Early Treatment of Diabetic Retinopathy Study) chart in both distance and near best-corrected visual acuity (BCVA) in the study eye. Ninety percent (172/192) of patients met or exceeded the study's protocol-specified visual acuity endpoint: a 2-line improvement in either distance or near BCVA. The study protocol required at least 50% of patients achieve this target. In addition to meeting the primary efficacy endpoint, secondary efficacy outcome measures indicated improvement in patients' vision-related quality of life and activities of daily living. Patients improved significantly from baseline (range 7 - 14 points; p < .01) in seven of eight relevant vision-specific and psychosocial subscales on the National Eye Institute 25-item Visual Function Questionnaire (VFQ). The safety and efficacy results were presented at scientific sessions at both the 109th Annual Meeting of the American Academy of Ophthalmology (AAO) and the AAO Retina Subspecialty Day meeting in Chicago. "Despite the recent advances in the treatment of AMD, there remain a large number of patients who progress to severe vision loss each year," stated Paul Sternberg, M.D., retina specialist and Chairman, Vanderbilt Eye Institute, who presented one-year data at the Retina Subspecialty Day meeting. "These patients can experience considerable improvement in visual function and quality of life from this novel device." In the trial, the telescope prosthetic device was implanted in one eye of patients with moderate to profound visual impairment (BCVA 20/80 - 20/800) in both eyes due to disciform scars (end-stage wet-AMD) or geographic atrophy (advanced dry AMD). Patients averaged 76 years of age. "This first-of-kind technology is an exciting development for both ophthalmologists and our patients," said Henry L. Hudson, M.D., investigator and retina specialist at Retina Centers, P.C., Tucson, AZ. "If approved for use, we would finally have an option for permanent improved central vision and independence for individuals with AMD who have difficulty with their everyday activities and hobbies, or who may feel isolated from society due to their vision." Dr. Hudson presented the safety and efficacy results at the AAO Retina Free Paper session. As was found in the Phase I study, the device was well tolerated in the eye. Preservation of vision, one of the two safety endpoints, was achieved in 95% of patients, exceeding the 90% protocol-specified target. Corneal endothelial cell density, the other safety endpoint (protocol-specified target 17%), was reduced 20% from baseline at 3 months and 25% at one year postoperatively. 206 of the 217 enrolled patients had the device successfully implanted in their eye, while 11 patients received a standard intraocular lens due to an aborted surgical procedure. The most common complications were transient increased intraocular pressure, transient corneal edema, and iris prolapse. The most common ocular adverse events were inflammatory or pigment deposits on the visual prosthesis, guttae, and posterior synechiae. Stephen S. Lane, M.D., Adjunct Professor of Ophthalmology, University of Minnesota, and in private practice at Associated Eye Care, Stillwater, MN, an anterior segment surgeon and the medical monitor for both the Phase I and current Phase II/III trials, presented the surgical and overall data in the AAO Vision Rehabilitation Program special meeting. "Across the 28 centers involved in this study, the surgeons reported that this unique visual prosthesis had excellent stability in the eye. We were pleased to see that this device continued to perform so well in this larger, pivotal trial," said Dr. Lane. Two-year follow-up, specified in the study protocol for long-term safety surveillance, is also now complete. "We appreciate the efforts and contributions of our clinical investigators participating in the pivotal study," commented Allen W. Hill, President and CEO of VisionCare Ophthalmic Technologies. "We look forward to completing the regulatory review process." The telescope prosthetic device, comprised of ultra-precision quartz glass micro-optics, is designed to be a permanent solution for moderate to profound vision loss due to AMD. Smaller than a pea, the telescope is implanted in one eye in an outpatient surgical procedure. In the implanted eye, the device renders enlarged central vision images over a wide area of the retina to improve central vision, while the non-operated eye provides peripheral vision for mobility and orientation.
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Caution: Investigational Device, Limited by Federal Law to Investigational Use. |