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

TBF Genie Tissulaire

Status and phase: Withdrawn; Phase 2

Conditions: Persistent Corneal Epithelial Defect; Corneal Ulcer

Treatments: Biological: LV-Visio-AMTRIX

Study type: Interventional

Funder types: Industry

Identifiers

NCT05172349

L-Visio-AMTRIX-TBF4

IDRCB (Other Identifier)

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

LV-Visio-AMTRIX

Experimental group

Description:

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

Treatment:

Biological: LV-Visio-AMTRIX