Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorVisionCare, Inc.
About this trial
The objective of this study is 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).
Eligibility criteria
Qualifiers
Be at least 65 years of age at the Pre-operative Visit;
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;
lack of need of treatment for CNV over the past 6 months, and
Disqualifiers
Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual training/rehabilitation with the device;
Stargardt macular dystrophy;
Diabetic retinopathy;
Untreated retinal tears;
Trial design
Treatments tested in this trial
- smaller incision, new generation implantable miniature telescope (SING-IMT)
Treatment groups
125 Participants
are divided into 1 treatment groupLocations
10California
Loma Linda University92354, Loma Linda United States
Eye Physicians of Long Beach90815, Long Beach United States
Florida
Sarasota Retina Institute34239, Sarasota United States
Massachusetts
Tallman Eye Associates01841, Lawrence United States
Sponsors and collaborators
VisionCare, Inc.
Lead sponsor
ORA, Inc.
Collaborator
Source ClinicalTrials.gov