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

Sponsor
TBF Genie Tissulaire (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05250583
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
41.1
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this open, mono center trial is to assess the impact of the use of an amniotic membrane on the healing of a keratitis resistant to medical treatment.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: LV-Visio-AMTRIX
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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 Keratitis Resisting Healing Medical Treatment
Actual Study Start Date :
Jun 29, 2020
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: LV-Visio-AMTRIX

Sutureless amniotic membrane supported by a biological ring.

Biological: LV-Visio-AMTRIX
Chemically-treated, viro-inactivated, freeze-dried and irradiated allograft placed by the investigator during patients' hospital visit

Outcome Measures

Primary Outcome Measures

  1. Keratitis healing within 15 days after the beginning of the treatment [15 days]

    Keratitis observed under slit lamp using fluorescein instillation. Keratitis considered healed if epithelialization of more than 50% and/or Oxford < grade 2

Secondary Outcome Measures

  1. Stable or decreased score for inflammatory and clinical signs of the ocular surface [1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days]

    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.

  2. Stabilisation or decrease of pain evaluated on visual analog scale [1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days]

    Visual Analog Scale (VAS) on 10 points from 0: no pain to 10: worst imaginable pain

  3. Preservation of epithelialization [15 days, 30 days, 45 days]

    Preservation of new epithelialization evaluated under slit lamp using fluorescein instillation and Oxford grading system

  4. Change in eye dryness [15 days, 30 days, 45 days]

    Eye dryness evaluated by the Ocular Surface Disease Index (OSDI) (0-12 = normal; 13-22 = mild dry eye; 23-32 = moderate dry eye; >33 = severe dry eye)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Male or female; age between 18 and 65 years.

  • Patient with non-infectious keratitis resistant to medical treatment for more than 15 days or recurrent after healing treatment.

  • Patient with quantitative and qualitative score for inflammatory ocular signs > 20.

  • Patient with Oxford grade > 2.

  • Informed and consenting patient with a relative or friend available to instill eye drops if necessary.

  • Patient affiliated to a social security system or beneficiary of such a system.

Exclusion Criteria:
  • Patient with active infectious keratitis (bacterial, parasitic or viral).

  • Patient with 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.

  • Patient with identified causes for the keratitis for which discontinuation of medical treatment beneficial.

  • Ocular surgery in the 3 months preceding the inclusion in the study.

  • Monophtalmic patient.

  • Person deprived of liberty by a judicial or administrative decision.

  • Adult subjected to a legal protection measure or unable to express his/her consent.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1CHU de Saint-Etienne Hôpital NordSaint-Priest-en-JarezFrance42270

Sponsors and Collaborators

  • TBF Genie Tissulaire

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
TBF Genie Tissulaire
ClinicalTrials.gov Identifier:
NCT05250583
Other Study ID Numbers:
  • L-Visio-AMTRIX-TBF3
  • 2019-A03144-53
First Posted:
Feb 22, 2022
Last Update Posted:
Mar 10, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2022