AMDNCT04796545
Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration
A study testing SING IMT(TM) System, model NG SI IMT 3X in people with AMD and Age-Related Macular Degeneration, run by VisionCare, Inc. at 13 sites in 7 countries.
Trial summary
The objective of this study is to demonstrate the safety and effectiveness of the SING IMT (Smaller Incision New Generation Implantable Miniature Telescope) 3X implant in improving vision in patients with central vision impairment associated with end-stage Age-related Macular Degeneration (AMD). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- AMD, Age-Related Macular Degeneration
- What is being tested?
- SING IMT(TM) System, model NG SI IMT 3X
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 13 sitesin 7 countries
- Study dates
- 13 Sep 2022to Dec 2028
- Phase
- Interventional
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
- Be 55 years of age or older.
- Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by fluorescein angiography or OCT.
- Have evidence of cataract.
- Have best-corrected distance visual acuity (BCDVA) no better than 20/80 (0.6 LogMAR) and no worse than 20/800 (1.6 LogMAR) in both eyes.
- Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation.
- Achieve at least a five-letter improvement on the ETDRS chart in the eye scheduled for surgery when using Samsara's 2.8X external telescope simulator (ETS, supplied separately).
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- Have an ACD of at least 2.5 mm in the eye scheduled for surgery.
- Be willing to participate in a post-operative training program for the use of the NG SI IMT 3X implant.
- Review and sign the Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-related procedures being performed.
- Have adequate understanding of the local language to understand verbal and written subject information and be willing to comply with the study requirements.
Who cannot join
- Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months.
- Any ophthalmic pathology that compromises the patient's peripheral vision in the fellow eye.
- A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperative IOP>22 mm Hg.
- Corneal guttata.
- Known sensitivity to post-operative medications.
- Significant communication impairment or severe neurological disorders.
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- Have undergone previous intraocular or corneal surgery of any kind in the operative eye, including any type of surgery for either refractive or therapeutic purposes.
- An ocular condition that predisposes the patient to eye rubbing.
- Prior or expected ophthalmic-related surgery within 30 days preceding the NG SI IMT 3X implant surgery.
- Patients for whom the planned operative eye has:
- Myopia > 6.0 D
- Hyperopia > 4.0 D
- Axial length < 21 mm
- Endothelial cell density < 1600 cells per square mm
- Narrow angle, i.e., < Schaffer grade 2.
- Inflammatory ocular disease.
- Cornea stromal or endothelial dystrophies, including guttata.
- Zonular weakness/instability of crystalline lens, or pseudoexfoliation.
- Diabetic retinopathy.
- Untreated retinal tears.
- Retinal vascular disease.
- Optic nerve disease.
- A history of retinal detachment.
- Retinitis pigmentosa.
- Intraocular tumor.
- Have received any investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study.
- Be an employee (or a relative of an employee) of the contract research organization (CRO) responsible for conducting the study, Sponsor, or Sponsor representative.
- Have a condition or be in a situation that, in the Investigator's opinion, may put the Subject at significant risk, may confound the study results, or may interfere significantly with the Subject's participation in the study.
Trial locations and contacts
13 sites in 7 countries.
13 sites in 7 countries
France3 sites
Centre d'Ophtalmologie Paradis-Monticelli
Marseille
Hélios Ophtalmologie, Saint-Jean-de-Luz
Saint-Jean-de-Luz
CHRU de Strasbourg
Strasbourg
Spain3 sites
VISSUM
Alicante
Institut OMIQ
Barcelona
Hospital Universitario La Luz - Quirónsalud
Madrid
Germany2 sites
Augenklinik Städtisches Klinikum Karlsruhe
Karlsruhe
Universitätsklinikum Münster Klinik für Augenheilkunde
Münster
Italy2 sites
Università degli Studi di Napoli Federico II
Naples
Fondazione Policlinico Universitario Agostino Gemelli
Roma
United Kingdom1 site
Royal Victoria Hospital Belfast Health & Social Care Trust
Belfast
About this study
Official title: A Prospective, Multicenter Post-marketing Clinical Investigation of the SING IMT(TM) System, Model NG SI IMT 3X in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration
The objective of this study is to demonstrate the safety and effectiveness of the SING IMT (Smaller Incision New Generation Implantable Miniature Telescope) 3X implant in improving vision in patients with central vision impairment associated with end-stage Age-related Macular Degeneration (AMD).
Eligible patients will be implanted with the SING IMT device and will be followed-up for a period of 12-months with post-operative ophthalmic exams and low-vision rehabilitation sessions.
Read the detailed description
This is an interventional, prospective, multicenter, open label, single group assignment Post-Market Clinical Follow-up (PMCF) study in men and women >=55 years with central vision impairment associated with end-stage AMD.
Following completion of informed consent, patients will be evaluated for eligibility to enroll into the study. Baseline visual acuity of the study subjects will be assessed with a 2.8X external telescope simulator (ETS) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts to determine if they are likely to benefit from receiving the IMT. To be included in the study and to proceed with the surgery, subjects must achieve, using the ETS, at least a one line (5 or more letters) improvement in distance on the ETDRS chart in the eye scheduled for surgery. Subjects not meeting these criteria will be excluded from the study.
If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery.
Postoperatively, the surgeon will complete a usability and satisfaction questionnaire after each implantation procedure.
The patients will undergo ophthalmic evaluations in both eyes at regular intervals for up to 12 months. The subjects will also be required to undergo 6 to 10 additional visits for vision training with a low vision specialist.
Surgical complications, as well as all Adverse Event (AEs) and use of medications will be monitored from baseline to the end of the study.
- Conditions
- AMD, Age-Related Macular Degeneration
- Being tested
- SING IMT(TM) System, model NG SI IMT 3X
- Keywords
- Age Related Macular Degeneration, Dry AMD, End-stage age-related macular degeneration, Central vision impairment, Geographic atrophy
- 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.
SING IMT(TM) System, model NG SI IMT 3XDevice
The SING IMT 3X implant is a visual prosthetic implantable device, which, when combined with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity in patients with bilateral, end-stage age-related macular degeneration.
| Study group | Role | What they receive |
|---|---|---|
| SING IMT System model NG SI IMT 3X | Experimental | All participants will be implanted with the SING IMT System model NG SI IMT 3X. Receives: Device: SING IMT(TM) System, model NG SI IMT 3X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the SING IMT System, model NG SI IMT 3X, including its delivery system
The percent decrease in endothelial cell density (ECD).
Measured: 12 months
Secondary outcomes (4)
Incision size needed for device implantation
Incision size will not exceed 8.0 mm (non-inferiority assumption) in 75% of surgeries
Measured: 12 moths
Surgical complications
AEs and serious adverse events
Measured: 12 moths
Improvement in near and distance best corrected visual acuity (BCVA) in implanted eyes.
Near and distance BCVA will show an improvement of ≥2 lines in the ETDRS chart in at least 50% (non-inferior to 50%) of the implanted eyes at 12 months post implantation.
Measured: 12 months
Usability of SING IMT System, including delivery system
Surgeon will complete a usability and satisfaction questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start13 Sep 2022
- Primary completionMay 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SING IMT(TM) System, model NG SI IMT 3X
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- VisionCare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796545
- Sponsor's protocol ID
- SING IMT PMCF
- Status last verified
- Sep 2026
- First submitted
- 3 Mar 2021
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No