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Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Trophic Ulcers | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

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

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

NCT05172349•TBF Genie Tissulaire

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

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
+3 more criteria

Key Dates

Start Date

April 1, 2022

Primary Completion Date

September 1, 2022

Completion Date

September 1, 2022

Last Updated

August 5, 2022

Conditions

Corneal UlcerPersistent Corneal Epithelial Defect

Interventions

LV-Visio-AMTRIX

BIOLOGICAL

Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease

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Persistent Corneal Epithelial DefectCorneal Epithelial Disorders

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RECRUITINGPHASE2

A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED

NCT05966493

Persistent Corneal Epithelial Defect

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 5, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease

A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED

OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate

Village Integrated Eye Workers Trial

Diagnosing Corneal Infection

Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers