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

TBF Genie Tissulaire0 sitesApril 2022

ConditionsCorneal Ulcer Persistent Corneal Epithelial Defect

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Corneal Ulcer
Sponsor: TBF Genie Tissulaire
Primary Endpoint: Largest diameter of persistent epithelial lesion area or corneal ulcer under 0.5 mm
Status: Withdrawn
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2022

End Date

September 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

TBF Genie Tissulaire

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Largest diameter of persistent epithelial lesion area or corneal ulcer under 0.5 mm

Time Frame: 15 days

Diameter assessed by centralized reading on photograph after fluorescein test

Secondary Outcomes

Recovery of the visual acuity evaluated by Monoyer chart(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)
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)