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Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Trophic Ulcers

Primary Purpose

Corneal Ulcer, Persistent Corneal Epithelial Defect

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
LV-Visio-AMTRIX
Sponsored by
TBF Genie Tissulaire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Ulcer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female between 18 and 80 years old
  • Stage 2 (persistent epithelial lesion : LEP) or stage 3 (corneal ulcer) trophic ulcer affecting only one eye. Patient whose contralateral eye is affected by stage 1 neurotrophic keratitis may also be included
  • Two or more weeks old LEP or corneal ulcer refractory to one or more conventional nonsurgical therapies
  • Absence of objective evidence of improvement of the epithelial ulceration or corneal ulcer within 2 weeks prior to study inclusion
  • Failure of amniotic membrane treatment of the trophic ulcer: failure by absence of healing a few day after overlay treatment or 15 days after inlay grafting
  • Patient able to understand French language
  • Informed and consenting patient
  • Patient affiliated to a social security system or beneficiary of such a system

Exclusion Criteria:

  • Pregnant or breastfeeding patient or without contraception for non-menopausal women
  • Active infectious ulcer
  • Preperforating ulcer or ulcer that has reached the posterior 1/3 of the storm
  • Allergy to Oxybuprocaine or Tetracaine eye drops, to ester type local anesthetics and to fluorescein
  • Current contact lens wear, including scleral lenses
  • NSAID eye drops and any drops containing preservatives
  • Antibiotic, anti-viral, anti-parasitic eye drops
  • Patients with identified causes of the ulcer for which medical treatment without preservatives or other healing treatment is beneficial
  • Ocular surgery for other pathology than the trophic ulcer in the 3 months preceding the inclusion in the study
  • Ophthalmologic pathology requiring daily eye drops
  • Monophtalmic patients
  • Persons deprived of liberty by a judicial or administrative decision
  • Adults who are subject to a legal protection measure or who are unable to express their consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    LV-Visio-AMTRIX

    Arm Description

    Sutureless amniotic membrane supported by a biological ring positioned by the investigator during patients' hospital visits.

    Outcomes

    Primary Outcome Measures

    Largest diameter of persistent epithelial lesion area or corneal ulcer under 0.5 mm
    Diameter assessed by centralized reading on photograph after fluorescein test

    Secondary Outcome Measures

    Recovery of the visual acuity evaluated by Monoyer chart
    Stable or decreased score for inflammatory and clinical signs of the ocular surface
    Composite score for inflammatory and clinical signs of the ocular surface on 66 points. Duration and intensity are evaluated for secretion, dry eyes, tearing, foreign body sensation, fluctuating vision, photophobia, burning sensation and lids edema. Duration is evaluated from a scale from 0: never to 4: all the time. Intensity is evaluated from a scale from 0: slight to 2: severe. Localization and intensity are evaluated for conjunctival edema, conjunctival redness and neovascularization. Localization is evaluated on a scale from 0: no reaction to 4: reaction present in the whole eye.
    Stabilisation or decrease of pain evaluated on visual analog scale
    VAS on 10 points from 0: no pain to 10: worst imaginable pain

    Full Information

    First Posted
    December 7, 2021
    Last Updated
    August 2, 2022
    Sponsor
    TBF Genie Tissulaire
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05172349
    Brief Title
    Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Trophic Ulcers
    Official Title
    Pilote Study of the Use of a Double Amniotic Membrane Inserted in a Ring of Umbilical Vessels With Wharton's Jelly, Tissues Treated by the AMTRIX Process, in the Treatment of Trophic Ulcers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Change in sponsor's strategy
    Study Start Date
    April 2022 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    September 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    TBF Genie Tissulaire

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this open, multicenter pilot trial is to assess the impact of the use of an amniotic membrane on the healing of a persistent epithelial lesion or of a corneal ulcer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Corneal Ulcer, Persistent Corneal Epithelial Defect

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LV-Visio-AMTRIX
    Arm Type
    Experimental
    Arm Description
    Sutureless amniotic membrane supported by a biological ring positioned by the investigator during patients' hospital visits.
    Intervention Type
    Biological
    Intervention Name(s)
    LV-Visio-AMTRIX
    Intervention Description
    Chemically-treated, viro-inactivated, freeze-dried and irradiated allograft placed by the investigator during patients' hospital visit
    Primary Outcome Measure Information:
    Title
    Largest diameter of persistent epithelial lesion area or corneal ulcer under 0.5 mm
    Description
    Diameter assessed by centralized reading on photograph after fluorescein test
    Time Frame
    15 days
    Secondary Outcome Measure Information:
    Title
    Recovery of the visual acuity evaluated by Monoyer chart
    Time Frame
    30 days, 45 days
    Title
    Stable or decreased score for inflammatory and clinical signs of the ocular surface
    Description
    Composite score for inflammatory and clinical signs of the ocular surface on 66 points. Duration and intensity are evaluated for secretion, dry eyes, tearing, foreign body sensation, fluctuating vision, photophobia, burning sensation and lids edema. Duration is evaluated from a scale from 0: never to 4: all the time. Intensity is evaluated from a scale from 0: slight to 2: severe. Localization and intensity are evaluated for conjunctival edema, conjunctival redness and neovascularization. Localization is evaluated on a scale from 0: no reaction to 4: reaction present in the whole eye.
    Time Frame
    2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days
    Title
    Stabilisation or decrease of pain evaluated on visual analog scale
    Description
    VAS on 10 points from 0: no pain to 10: worst imaginable pain
    Time Frame
    2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female between 18 and 80 years old Stage 2 (persistent epithelial lesion : LEP) or stage 3 (corneal ulcer) trophic ulcer affecting only one eye. Patient whose contralateral eye is affected by stage 1 neurotrophic keratitis may also be included Two or more weeks old LEP or corneal ulcer refractory to one or more conventional nonsurgical therapies Absence of objective evidence of improvement of the epithelial ulceration or corneal ulcer within 2 weeks prior to study inclusion Failure of amniotic membrane treatment of the trophic ulcer: failure by absence of healing a few day after overlay treatment or 15 days after inlay grafting Patient able to understand French language Informed and consenting patient Patient affiliated to a social security system or beneficiary of such a system Exclusion Criteria: Pregnant or breastfeeding patient or without contraception for non-menopausal women Active infectious ulcer Preperforating ulcer or ulcer that has reached the posterior 1/3 of the storm Allergy to Oxybuprocaine or Tetracaine eye drops, to ester type local anesthetics and to fluorescein Current contact lens wear, including scleral lenses NSAID eye drops and any drops containing preservatives Antibiotic, anti-viral, anti-parasitic eye drops Patients with identified causes of the ulcer for which medical treatment without preservatives or other healing treatment is beneficial Ocular surgery for other pathology than the trophic ulcer in the 3 months preceding the inclusion in the study Ophthalmologic pathology requiring daily eye drops Monophtalmic patients Persons deprived of liberty by a judicial or administrative decision Adults who are subject to a legal protection measure or who are unable to express their consent

    12. IPD Sharing Statement

    Learn more about this trial

    Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Trophic Ulcers

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