NCT04796545

Brief 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). 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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
7 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Sep 2022Dec 2028

First Submitted

Initial submission to the registry

March 3, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 13, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

February 10, 2026

Status Verified

November 1, 2025

Enrollment Period

4.4 years

First QC Date

March 3, 2021

Last Update Submit

February 5, 2026

Conditions

AMDAge-Related Macular Degeneration

Keywords

Age Related Macular DegenerationDry AMDEnd-stage age-related macular degenerationCentral vision impairmentGeographic atrophy

Outcome Measures

Primary Outcomes (1)

  • Safety of the SING IMT System, model NG SI IMT 3X, including its delivery system

    The percent decrease in endothelial cell density (ECD).

    12 months

Secondary Outcomes (4)

  • Incision size needed for device implantation

    12 moths

  • Surgical complications

    12 moths

  • Improvement in near and distance best corrected visual acuity (BCVA) in implanted eyes.

    12 months

  • Usability of SING IMT System, including delivery system

    12 months

Other Outcomes (2)

  • Device stability and fixation

    12 months

  • Post-operative anterior chamber depth (ACD)

    12 months

Study Arms (1)

SING IMT System model NG SI IMT 3X

EXPERIMENTAL

All participants will be implanted with the SING IMT System model NG SI IMT 3X.

Device: SING IMT(TM) System, model NG SI IMT 3X

Interventions

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.

SING IMT System model NG SI IMT 3X

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

UZ Brussel

Brussels, Belgium

RECRUITING

Centre d'Ophtalmologie Paradis-Monticelli

Marseille, France

RECRUITING

Hélios Ophtalmologie, Saint-Jean-de-Luz

Saint-Jean-de-Luz, France

RECRUITING

CHRU de Strasbourg

Strasbourg, France

RECRUITING

Augenklinik Städtisches Klinikum Karlsruhe

Karlsruhe, Germany

TERMINATED

Universitätsklinikum Münster Klinik für Augenheilkunde

Münster, Germany

RECRUITING

Mater Misericordiae University Hospital

Dublin, Ireland

RECRUITING

Università degli Studi di Napoli Federico II

Naples, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy

RECRUITING

VISSUM

Alicante, Spain

RECRUITING

Institut OMIQ

Barcelona, Spain

RECRUITING

Hospital Universitario La Luz - Quirónsalud

Madrid, Spain

RECRUITING

Royal Victoria Hospital Belfast Health & Social Care Trust

Belfast, United Kingdom

RECRUITING

MeSH Terms

Conditions

Macular DegenerationGeographic Atrophy

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Central Study Contacts

Anne Roller, PhD

CONTACT

+ 33 (0)3 88 30 88 11clinicals@medevise-consulting.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: SING IMT(TM) System, model NG SI IMT 3X
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 15, 2021

Study Start

September 13, 2022

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

February 10, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)GB(1)DE(2)IE(1)IT(2)BE(1)FR(3)