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 groupSponsors and collaborators
VisionCare, Inc.
Lead sponsor
ORA, Inc.
Collaborator
Source ClinicalTrials.gov