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

NCT ID: NCT05172349

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2022-09-30

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.

Conditions

Corneal Ulcer; Persistent Corneal Epithelial Defect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LV-Visio-AMTRIX

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

Group Type: EXPERIMENTAL

LV-Visio-AMTRIX

Intervention Type: BIOLOGICAL

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

Interventions

LV-Visio-AMTRIX

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TBF Genie Tissulaire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IDRCB

Identifier Type: REGISTRY

Identifier Source: secondary_id

L-Visio-AMTRIX-TBF4

Identifier Type: -

Identifier Source: org_study_id