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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Corneal Ulcer; Persistent Corneal Epithelial Defect
• Intervention / Treatment: Biological: LV-Visio-AMTRIX

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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 positioned by the investigator during patients' hospital visits.	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
Largest diameter of persistent epithelial lesion area or corneal ulcer under 0.5 mm	Diameter assessed by centralized reading on photograph after fluorescein test	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery of the visual acuity evaluated by Monoyer chart		30 days, 45 days
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.	2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days
Stabilisation or decrease of pain evaluated on visual analog scale	VAS on 10 points from 0: no pain to 10: worst imaginable pain	2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days

Collaborators and Investigators

• Sponsor: TBF Genie Tissulaire

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 27, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Eye Diseases; Keratitis; Corneal Diseases; Eye Infections; Ulcer; Corneal Ulcer
• Other Study ID Numbers: L-Visio-AMTRIX-TBF4; IDRCB (Registry Identifier: 2022-A02601-42)

Drug and device information, study documents

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