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

NCT05172349 | Withdrawn Phase 2

• 2 other identifiers: L-Visio-AMTRIX-TBF4IDRCB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days

• Stabilisation or decrease of pain evaluated on visual analog scale

  2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days

Study Arms (1)

LV-Visio-AMTRIX

EXPERIMENTAL

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

Biological: LV-Visio-AMTRIX

Interventions

LV-Visio-AMTRIX BIOLOGICAL

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

LV-Visio-AMTRIX

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• TBF Genie Tissulaire: lead

MeSH Terms

Conditions

Corneal Ulcer

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Keratitis; Corneal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 29, 2021
• Study Start: April 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08