Actively Recruiting // Age-related Macular Degeneration // Clinical Trials // Sarah Nehls // Oct 07 2022
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
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).
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.
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
Have any of the following conditions at the Pre-operative Visit:
Stargardt macular dystrophy;
Untreated retinal tears;
Retinal vascular disease;
Optic nerve disease;
History of retinal detachment;
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.