The Implantable Miniature Telescope in Patients with Macular Degeneration – Results of the Phase II/III IMT–002 Trial at Three Months

Abstract

Abstract: : Purpose: Late–stage age–related macular degeneration (AMD), defined as exudative or disciform AMD and geographic atrophy, is the leading cause of blindness in individuals over age 55. Despite recent advances in the treatment of exudative AMD, and with an absence of treatment options for geographic atrophy and disciform scars, patients with stable late–stage AMD generally suffer from moderate to severe vision loss as defined by ICD–9–CM (20/80 – 20/400). The Implantable Miniature Telescope (IMT)* is a visual prosthetic device designed to address debilitating central vision loss by rendering enlarged retinal images of the central visual field onto the central and peripheral retina. The purpose of this study is to prospectively evaluate the safety and efficacy of the IMT in patients with moderate to profound bilateral central vision loss due to late–stage AMD, or Stargardt’s macular dystrophy. Methods: 217 patients with geographic atrophy or disciform scar AMD, or Stargardt’s macular dystrophy, were enrolled for monocular implantation of the IMT. Criteria for enrollment included bilateral stable AMD with no evidence of active CNV on fluorescein angiography, nor treatment of CNV within the previous six months. Inclusion criteria included best–corrected visual acuity (BCVA) of 20/80 – 20/800, endothelial cell density (ECD) above 1600 cells/mm², evidence of cataract, and a minimum of a 5–letter improvement on the ETDRS chart using an external telescope. Primary outcomes are distance and near BCVA for efficacy and ECD for safety. Secondary outcomes include the VFQ–25 and Activities of Daily Living (ADL) questionnaires, which are administered pre– and post–operatively to assess subjective changes in quality of life. Results: At baseline, mean distance BCVA was 20/300. Visual impairment was moderate (20/80 to 20/200), severe (20/200 to 20/500), and profound (20/500 to 20/800) in 16%, 62%, and 22% of study patients, respectively. Mean age was 76, with 52% male. Conclusion: A visual prosthetic device, the IMT, is being evaluated in patients with stable, sight–depriving macular degeneration in this prospective, multi–center clinical trial. Safety and efficacy results at three months are to be presented. *IMT^TMby Dr. Isaac Lipshitz, VisionCare Ophthalmic Technologies, Inc., Saratoga, CA

Keywords: age–related macular degeneration