Results of Implantable Telescope Trial Published in Ophthalmology Report on Vision and Quality of Life in Patients With End-Stage Age-Related Macular Degeneration
-Publication Details Study on Leading Cause of Blindness in Seniors,
SARATOGA, Calif., Nov. 1 /PRNewswire/ -- VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices for the treatment of age-related macular degeneration (AMD), today announced that results from the Phase II/III clinical trial of the investigational Implantable Miniature Telescope (IMT(TM) by Dr. Isaac Lipshitz) have been published in the November issue of Ophthalmology, the official journal of the American Academy of Ophthalmology. The publication documents a potential new treatment model for an unmet medical need -- irreversible vision loss due to bilateral end-stage AMD. The Ophthalmology article entitled "Implantable Miniature Telescope for the Treatment of Visual Acuity Loss Resulting from End-Stage Age-Related Macular Degeneration," details the results from the IMT002 trial which enrolled 217 patients at 28 U.S. investigational sites. Patients entering the trial had severe vision loss due to the characteristic central blind spot caused by end-stage macular degeneration. The publication reports 90% of patients met or exceeded the protocol-specified primary efficacy endpoint of visual improvement, defined as a 2-line gain in either distance or near vision on the study eye chart. The protocol stated the endpoint would be achieved if at least 50% of patients met this target. "This is truly a breakthrough because it is the first clinical trial to show the potential for improved vision and quality of life specifically in patients with bilateral, irreversible AMD," said Henry L. Hudson, M.D., lead author of the IMT002 study publication and retina specialist at Retina Centers, P.C. in Tucson, AZ. "From an efficacy standpoint, we hoped that half of this study population with untreatable forms of AMD could achieve at least a 2-line visual acuity gain. The results surpassed our expectations because ninety percent achieved the efficacy endpoint, and, furthermore, over two- thirds of patients improved by at least three lines and one-quarter improved by at least five lines in distance vision." At 1 year after the telescope implantation procedure, 67% of patients achieved a 3-line (doubling of vision) or greater improvement in their study eye distance visual acuity, compared with 13% of unimplanted fellow eye controls. Approximately 25% of telescope-implanted eyes achieved a 5-line or greater improvement in visual acuity, compared with 2% of fellow eyes. Loss of 3 lines or more was encountered in 1.6% of implanted eyes, compared with 3.1% of fellow eyes. Secondary efficacy outcome measures suggest improvement in patients' vision-related quality of life and activities of daily living. On the National Eye Institute 25-item Visual Function Questionnaire, patients improved significantly from baseline (range 7 to 14 points) in 7 of 8 relevant vision-specific and psychosocial subscales, including General Vision, Social Functioning, and Dependency. Corneal endothelial cell density, a safety endpoint, was reduced 20% from preoperative at 3 months and 25% at one year (compared with the 17% protocol-specified target). "In an end-stage AMD population, the indicated improvements in this study are substantial compared to risks of surgery," commented R. Doyle Stulting, M.D., Ph.D, professor of ophthalmology at Emory University in Atlanta, and study coauthor. "For patients with this level of visual impairment, the ability to be less dependent on others and to reclaim even a few of the activities they once enjoyed could make a real difference in their lives." Patients enrolled in the study were at least 55 years of age and had central vision loss caused by disciform scars (end-stage wet AMD) or geographic atrophy (advanced dry AMD). Exclusion criteria included active choroidal neovascularization (wet AMD) or treatment of wet AMD in the preceding six months. Patients with early-stage AMD, mildly visually impairing AMD, or unilateral affection were not eligible. "This study is important in the current era of new retinal treatments for patients with macular disease," said study coauthor Jeffrey S. Heier, M.D., assistant professor at Tufts University School of Medicine and in private practice at Ophthalmic Consultants of Boston. "Despite the unprecedented progress we have made in treatments for wet AMD over the past decade, there are still no medical or surgical options available for patients with end-stage wet AMD or geographic atrophy. The results of this study suggest the potential for meaningful outcomes for a patient population for which we've had virtually no options to improve vision." The IMT002 trial was a prospective, open-label, multicenter clinical trial conducted under an investigational device exemption from the U.S. Food and Drug Administration (FDA). Patients averaged 76 years of age. The telescope prosthesis was generally well tolerated in the eye. 206 of the 217 enrolled patients had the device successfully implanted in their study eye, while 11 patients received a standard intraocular lens due to an aborted procedure. The most common complications or adverse events included transient intraocular pressure, transient corneal edema, iris prolapse, and inflammatory deposits on the device. There were 2 cases of corneal decompensation. The published results can be found online at http://www.ophsource.org/periodicals/ophtha/article/PIIS016164200600933X/ab str act . "Despite the endothelial cell loss from surgery, we believe that corneal health was maintained," said 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. "There was a significant correlation between postoperative cell loss and the level of corneal edema on the first postoperative day. Therefore, it appears that the majority of cell loss was due to the impact of the surgical procedure. Stabilization of cell density three to twelve months after surgery was consistent with what we'd expect after large-incision intraocular surgery. While the techniques required to implant the device are well within the skill set of anterior segment surgeons, a surgeon training program will be utilized to address the risk of acute endothelial cell density loss during implant." About the Telescope Prosthetic Device The investigational Implantable Miniature Telescope (IMT(TM) by Dr. Isaac Lipshitz) is designed to be a permanent solution for moderate to profound vision loss due to advanced, end-stage forms of AMD that have no current surgical or medical treatment options. Smaller than a pea, the telescope prosthetic device 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. The prospective, multicenter IMT002 Phase II/III trial was designed to evaluate the safety and efficacy of VisionCare's investigational medical device in individuals with moderate to profound bilateral central vision impairment associated with end-stage AMD. Based on data included in the published results and from ongoing patient follow-up, VisionCare filed a Premarket Approval (PMA) application for the telescope prosthesis. The PMA submission sought market approval for the treatment of central vision loss due to advanced, irreversible forms of AMD. Subsequent to a July 2006 FDA Ophthalmic Devices Advisory Panel meeting, FDA issued a letter to VisionCare citing deficiencies in the application that must be addressed to place the regulatory submission in approvable form. The issues primarily relate to ascertaining if reduction in corneal endothelial cell density is due to endothelium remodeling or other factors, and determining the contribution of cataract removal to the improvement in visual acuity. No additional clinical investigations have been requested. VisionCare currently projects submitting a response to FDA in the first quarter of 2007. Assuming no significant additional analyses or clinical data are required, the Company projects regulatory approval in the second half of 2007. About Macular Degeneration Macular degeneration is a disorder of the central retina, or macula, which is responsible for detailed vision that controls important functional visual activities like reading, recognizing faces, and watching television. According to the National Eye Institute over 1.7 million Americans over age 50 suffer mild to profound vision loss from advanced AMD, which frequently culminates as end-stage AMD (visual impairment due to untreatable advanced AMD). Patients affected in both eyes often experience a loss of independence, social interaction, and have difficulty with activities of daily living requiring detailed vision. Approximately half of the individuals living with advanced AMD are affected in both eyes. About VisionCare VisionCare Ophthalmic Technologies, Inc., headquartered in Saratoga, CA is a privately-held company focused on development, manufacturing, and marketing of visual prosthetic devices. The Implantable Miniature Telescope was invented by company founders, Isaac Lipshitz, M.D., and Yossi Gross. Information on VisionCare can be found at www.visioncareinc.net .
SOURCE VisionCare Ophthalmic Technologies, Inc.
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