NCT05941273

Brief 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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 3, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

July 30, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

July 12, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

July 3, 2023

Last Update Submit

July 3, 2023

Conditions

Age-Related Macular DegenerationGeographic Atrophy

Keywords

Implantable Miniature Telescope

Outcome Measures

Primary Outcomes (1)

  • Safety: Endothelial cell density

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

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

Secondary Outcomes (1)

  • Adverse Events

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

Study Arms (1)

Implanted Eye with SING IMT

EXPERIMENTAL

The SING IMT is implanted in on eye and safety endpoints are aimed at following that eye over time post-implant

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

Interventions

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)

Implanted Eye with SING IMT

Eligibility Criteria

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

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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;
  • 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;
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson Medical Center

Holon, Tel Aviv, 5822012, Israel

Location

MeSH Terms

Conditions

Macular DegenerationGeographic Atrophy

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Guy Kleinman, MD

    Wolfson Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Kammer, OD, PhD

CONTACT

+1(714)728-1575rkammer@samsaravision.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
As the IMT has a unique appearance in the eye, it cannot be masked to the Investigator or to the patient
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single site case series
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 12, 2023

Study Start

July 30, 2023

Primary Completion

January 30, 2024

Study Completion

January 30, 2025

Last Updated

July 12, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)