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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
smaller incision, new generation implantable miniature telescope (SING-IMT)
DeviceThe IMT (model SING) is an intraocular implant comprised of 2 micro lenses in a glass tube (optics) in a flexible silicone carrier (haptics)
Treatment groups
125 Participants
are divided into 1 treatment groupGroup A: SING-IMT ImplantedExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Effectiveness Outcome
Proportion of study eyes with an improvement of 10 or more ETDRS letters (0.2 logMAR) in either BCDVA or BCNVA at Visit 5 (330 to 420 days post-operatively) compared to Pre-operative Visit
Time frame
Approximately 12-months post-operatively (330-420 days)2
Primary Safety Outcome
Percent change in endothelial cell density (ECD) from Pre-operative Visit in study eyes at Visit 5 (330 to 420 days post-operatively)
Time frame
Approximately 12-months post-operatively (330-420 days)Secondary outcomes
1
Best-corrected distance visual acuity (BCDVA)
Post-operative BCDVA in study eyes at Visit 5 (330 to 420 days post-operatively) compared to Pre-operative Visit
Time frame
Approximately 12-months post-operatively (330-420 days)2
Best-corrected near visual acuity (BCNVA)
Post-operative BCNVA in study eyes at Visit 5 (330 to 420 days post-operatively) compared to Pre-operative Visit
Time frame
Approximately 12-months post-operatively (330-420 days)3
Anterior Chamber Depth
Anterior Chamber Depth in study eyes, defined as the distance between the corneal endothelium and the front surface of the IMT, at Visit 5 (330 to 420 days post-operatively)
Time frame
Approximately 12-months post-operatively (330-420 days)4
IMT position
IMT tilt and centration in study eyes at Visit 5 (330 to 420 days post-operatively)
Time frame
Approximately 12-months post-operatively (330-420 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
VisionCare, Inc.
Lead sponsor
ORA, Inc.
Collaborator
Source ClinicalTrials.gov