Ophthalmology and Visual Sciences

CONCERTO

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A Prospective, Multicenter Clinical Study of the Implantable Miniature Telescope, Model SING in Patients with Central Vision Impairment Associated with End-Stage Age-Related Macular Degeneration (CONCERTO)

  • Sponsor: VisionCare, Inc.
  • Principal Investigator: Sarah Nehls, MD
  • Study Coordinator: Kris Dietzman

Study objective:

To determine the safety and effectiveness of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD).

Study design:

This is a prospective, multicenter, open-label pivotal study. Participants will undergo cataract surgery and IMT implantation after screening and complete 5 study visits in approximately 12-15 months.

Inclusion criteria:

    • Be at least 65 years of age
    • Have ETDRS BCDVA 0.9 to 1.6 logMAR (20/160 to 20/800) at the Pre-operative Visit caused by bilateral central scotomas associated with end-stage AMD;
    • Have bilateral retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by standard of care fluorescein angiography (FA) prior to the Pre-operative Visit;
    • Have been monitored by an eye care professional over the 6-month (or longer) period immediately prior to the Pre-operative Visit and have demonstrated no evidence of active choroidal neovascularization (CNV) prior to the Pre-operative Visit as demonstrated by the following:
      • lack of need of treatment for CNV over the past 6 months, and
      • lack of active exudative fluid on optical coherence tomography (OCT) over the past 6 months, and
      • lack of Retinal hemorrhage on exam over a 6-month period or longer
    • Agree to participate in post-operative visual training

Exclusion criteria:

    • Have any of the following conditions at the Pre-operative Visit:
      • Stargardt macular dystrophy;
      • Diabetic retinopathy;
      • Untreated retinal tears;
      • Retinal vascular disease;
      • Optic nerve disease;
      • History of retinal detachment;
      • Intraocular tumor;
      • Retinitis pigmentosa;
    • History of steroid-induced rise in intraocular pressure (IOP), uncontrolled glaucoma, or IOP >22 mmHg at the Pre-operative Visit;
    • History of eye rubbing or an ocular condition that predisposes subject to eye rubbing;

Contact Kris Dietzman with questions: 608-263-9035.

For more information about this study visit:

CLINICALTRIALS.GOV