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

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

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.

Study Overview

• Status: Terminated
• Conditions: Keratitis
• Intervention / Treatment: Biological: LV-Visio-AMTRIX

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Saint-Priest-en-Jarez, France, 42270
    • CHU de Saint-Etienne Hôpital Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keratitis healing within 15 days after the beginning of the treatment	Keratitis observed under slit lamp using fluorescein instillation. Keratitis considered healed if epithelialization of more than 50% and/or Oxford < grade 2	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days
Stabilisation or decrease of pain evaluated on visual analog scale	Visual Analog Scale (VAS) on 10 points from 0: no pain to 10: worst imaginable pain	1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days
Preservation of epithelialization	Preservation of new epithelialization evaluated under slit lamp using fluorescein instillation and Oxford grading system	15 days, 30 days, 45 days
Change in eye dryness	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)	15 days, 30 days, 45 days

Collaborators and Investigators

• Sponsor: TBF Genie Tissulaire

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): January 7, 2021
• Study Completion (Actual): January 7, 2021

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratitis
• Other Study ID Numbers: L-Visio-AMTRIX-TBF3; 2019-A03144-53 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No