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Age-Related Macular DegenerationNCT05941273

A Study of the SING IMT in an Israeli Cohort

A study testing smaller incision, new generation implantable miniature telescope (SING-IMT) in people with Age-Related Macular Degeneration and Geographic Atrophy, run by VisionCare, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The objective of this single center study is to determine the safety of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in a small sample of patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD) in an Israeli Cohort Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
smaller incision, new generation implantable miniature telescope (SING-IMT)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
30 Jul 2023to 5 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For Both Eyes:
  • Be at least 55 years of age at the Pre-operative Visit;
  • Have ETDRS BCDVA 0.6 to 1.6 logMAR (20/80 to 20/800) at the Pre-operative Visit;
  • Have bilateral retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by fluorescein angiography (FA) or OCT;
  • Have an Endothelial Cell Density (ECD) above 1800 cells per millimeter;
  • Have central anterior chamber depth (ACD) >2.5 mm from the posterior surface of the cornea (endothelium) to the anterior surface of the crystalline lens at the Pre-operative Visit;
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  • Agree to participate in post-operative visual training
  • For the Implanted Eye:
  • Have evidence of visually significant cataract at the Pre-operative Visit;
  • Agree to undergo pre-operative assessment with low vision specialists (optometrist, occupational therapist or other professional with low vision experience) in the use of an external telescope model sufficient for patient assessment and patient must achieve at least a 5-letter ETDRS BCDVA improvement (0.1 logMAR) in the final assessment
  • For the Non-Implanted Eye:
  • -Have adequate peripheral vision at the Pre-operative Visit to allow navigation.

Who cannot join

  • For Both Eyes:
  • Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual training/rehabilitation with the device;
  • Have evidence of bilateral active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months.
  • Have any of the following conditions at the Pre-operative Visit:
  • Stargardt macular dystrophy;
  • Diabetic retinopathy;
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  • 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;
  • Have known allergy to post-operative medications;
  • History of eye rubbing or an ocular condition that predisposes subject to eye rubbing;
  • Have had prior or expected ophthalmic surgery within 30 days of the Operative Visit;
  • Have any circumstance that, based on the Investigator's judgment, poses a concern for the subject's safety;
  • Any systemic disease or clinical evidence of any condition at the Pre-operative Visit which would make the subject in the opinion of the investigator unsuitable for the study;
  • Concurrent participation or prior participation in any investigative drug or device study within last 30 days prior to Pre-operative Visit.
  • For the Implanted Eye:
  • Have a history of corneal stromal or endothelial dystrophies, including guttata;
  • Have Myopia > 6.0 D or Hyperopia > 4.0 D by Manifest Refraction at the Pre-operative Visit;
  • Have an Axial Length (AL) < 21 mm at the Pre-operative Visit;
  • Have a narrow angle defined as < grade 2 on the Schaffer scale at the Pre-operative Visit;
  • Ongoing Inflammatory ocular disease at the Pre-operative Visit;
  • Zonular weakness/instability of crystalline lens, or pseudoexfoliation at the Pre-operative Visit;
  • Have any condition at the Pre-operative Visit which in the judgement of the Investigator indicates that the haptics cannot be placed within the capsular bag during surgery;
  • Have had previous intraocular or corneal surgery, including any type of surgery for refractive or therapeutic purposes;
  • For the Non-Implanted Eye:
  • -Have ophthalmic pathology at the Pre-operative Visit that compromises the patient's peripheral vision based on the Investigator's judgment.

About this study

Official title: A Study of the Implantable Miniature Telescope, Model SING (SING IMT) in Patients With Central Vision Impairment Associated With End-stage Age Related Macular Degeneration in an Israeli Cohort

The objective of this single center study is to determine the safety of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in a small sample of patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD) in an Israeli Cohort

Read the detailed description

The SING IMT has CE Mark in the EU and has been implanted in over 200 patients globally including a pivotal study in the U.S. currently underway (the Concerto Study) and a post-marketing study in EU (The PMCF Study). Model SING is a new injectable model based on the IMT parent model (PMA P050034). Following completion of informed consent, patients will be evaluated for eligibility to enroll into the study, including assessment of their best-corrected distance- and near- visual acuity with refraction, and also when using an external telescope simulator to determine if they are likely to benefit from receiving the SING IMT. If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery in one eye. Following implantation, patients will return for 5 post-operative follow-up visits over a period of approximately 12 months. Additionally, patients will have up to 10 rehabilitation/training visits with a low vision specialist to learn how to use the fellow eye for ambulation and the eye with the implant for magnified viewing during daily activities.

Being tested
smaller incision, new generation implantable miniature telescope (SING-IMT)
Keywords
Implantable Miniature Telescope
Medical subject headings
Macular Degeneration, Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • smaller incision, new generation implantable miniature telescope (SING-IMT)Device

    The IMT (model SING) is an intraocular implant comprised of 2 micro lenses in a glass tube (optics) in a flexible silicone carrier (haptics)

Study groups in NCT05941273
Study groupRoleWhat they receive
Implanted Eye with SING IMTExperimentalThe SING IMT is implanted in on eye and safety endpoints are aimed at following that eye over time post-implant
Receives: Device: smaller incision, new generation implantable miniature telescope (SING-IMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: Endothelial cell density

    Percent change in endothelial cell density (ECD) from Pre-operative Visit in study

    Measured: Comparison of baseline to Visit 5 (330 to 420 days post-operatively)

Secondary outcomes (1)

  1. Adverse Events

    Rates of adverse events from Operative Visit through Visit 5

    Measured: Approximately 12-months post-operatively (330-420 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2023
  2. Study start30 Jul 2023 (estimated)
  3. Primary completion30 Jan 2024 (estimated)
  4. Study completion5 Feb 2026

Why it stopped: This decision is driven by the sponsor's strategic considerations.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single site case series
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05941273
Sponsor's protocol ID
CDV-SNG 001
Status last verified
May 2026
First submitted
3 Jul 2023
Last updated
18 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing smaller incision, new generation implantable miniature telescope (SING-IMT) in people with Age-Related Macular Degeneration and Geographic Atrophy, run by VisionCare, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: Endothelial cell density (time frame: Comparison of baseline to Visit 5 (330 to 420 days post-operatively)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05941273.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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