Agree to participate in post op visual training Achieve 5 letter improvement with an external telescope Retinal findings of geographic atrophy or disciform scar Clinical parameters for both eyes: slit lamp & fundus exams, BCVA, IOP and corneal endothelial cell density measurement. market approvalĬlinical Summary: Patients will be closely followed for 5 years post implantation. General Summary: The purpose of the IMT PAS 01 is to evaluate the safety of the intraocular telescope for the treatment of bilateral end-stage age-related macular degeneration following U.S. Inadequately responsive to the most recent anti-VEGF therapyĬontact: Donna Leef, MMSc, COMT (404) 778-4134 05-18-2015Ī Prospective, Multicenter Post-Approval Study of VisionCare's Implantable Miniature Telescope in Patients with Bilateral Severe to Profound Central Vision Impairment Associated with End-Stage Age-Related Macular Degeneration.Scar and/or, fibrosis: More than 25% of the total lesion size in the study eye scar, fibrosis or atrophy (includingRPE) involving the center of the fovea as determined by the reading center.Subretinal hemorrhage: More than 50% of total lesion size in the study eye, as determined by the central reading center.Vision 20/40 to 20/320 in the study eye and at least 20/200 in the non-study eye.Must have received at least 3 intravitreal anti-VEGF injections (Avastin®, Lucentis® or Eylea®) in the study eye with at least 1 injection of Avastin® or Lucentis® or Eylea® in the previous 4 months.Active (recurrent or persistent) subfoveal CNV lesions secondary to AMD, as determined by the reading center,in at least 1 eye, the study eye at the screening visit.The study will compare the safety and efficacy of the NT-503-3 ECT implanted in the eye to the Eylea® injection treatment every 8 weeks that is already available for wet AMD. The goal of this treatment is to ultimately avoid the need for frequent injections into the eye. The ECT implant is surgically implanted into the eye with a minor procedure under local anesthesia. The NT-503-3 ECT implant contains tiny capsules (smaller than a grain of rice) of living cells that continuously release a soluble VEGF receptor for an extended period. This study will assess whether this experimental implant can be used to treat people with reoccurring wet AMD. This investigational treatment is called the NT-503-3 intraocular encapsulated cell technology (ECT) implant. This research study is for an investigational new treatment a treatment that has not yet been approved for marketing by regulatory authorities. NTMT503 A Multi-Center, Two-Stage, Open-Label Phase I and Randomized, Active Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology Compared with Eylea® for the Treatment of Recurrent Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

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