Clinical trial NCT05172349: Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Trophic Ulcers
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Corneal Ulcer
Persistent Corneal Epithelial Defect
Lead sponsor: TBF Genie Tissulaire
Sponsor class: INDUSTRY
First posted: 2021-12-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Largest diameter of persistent epithelial lesion area or corneal ulcer under 0.5 mm
timeFrame: 15 days
Secondary outcomes:
measure: Recovery of the visual acuity evaluated by Monoyer chart
timeFrame: 30 days, 45 days
measure: Stable or decreased score for inflammatory and clinical signs of the ocular surface
timeFrame: 2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days
measure: Stabilisation or decrease of pain evaluated on visual analog scale
timeFrame: 2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days
Other outcomes:
Locations:
Study officials:
References: