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

NCT05250583 | Terminated Phase 2

• 2 other identifiers: L-Visio-AMTRIX-TBF32019-A03144-53
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this open, mono center trial is to assess the impact of the use of an amniotic membrane on the healing of a keratitis resistant to medical treatment.

Conditions

Keratitis

Outcome Measures

Primary Outcomes (1)

• Keratitis healing within 15 days after the beginning of the treatment

  Keratitis observed under slit lamp using fluorescein instillation. Keratitis considered healed if epithelialization of more than 50% and/or Oxford \< grade 2

  15 days

Secondary Outcomes (4)

• Stable or decreased score for inflammatory and clinical signs of the ocular surface

  1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days

• Stabilisation or decrease of pain evaluated on visual analog scale

  1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days

• Preservation of epithelialization

  15 days, 30 days, 45 days

• Change in eye dryness

  15 days, 30 days, 45 days

Study Arms (1)

LV-Visio-AMTRIX

EXPERIMENTAL

Sutureless amniotic membrane supported by a biological ring.

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

You may qualify if:

• Male or female; age between 18 and 65 years.
• Patient with non-infectious keratitis resistant to medical treatment for more than 15 days or recurrent after healing treatment.
• Patient with quantitative and qualitative score for inflammatory ocular signs \> 20.
• Patient with Oxford grade \> 2.
• Informed and consenting patient with a relative or friend available to instill eye drops if necessary.
• Patient affiliated to a social security system or beneficiary of such a system.

You may not qualify if:

• Patient with active infectious keratitis (bacterial, parasitic or viral).
• Patient with 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.
• Patient with identified causes for the keratitis for which discontinuation of medical treatment beneficial.
• Monophtalmic patient.
• Person deprived of liberty by a judicial or administrative decision.
• Adult subjected to a legal protection measure or unable to express his/her consent.

Sponsors & Collaborators

• TBF Genie Tissulaire: lead

Study Sites (1)

CHU de Saint-Etienne Hôpital Nord

Saint-Priest-en-Jarez, 42270, France

Location

MeSH Terms

Conditions

Keratitis

Condition Hierarchy (Ancestors)

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: February 10, 2022
• First Posted: February 22, 2022
• Study Start: June 29, 2020
• Primary Completion: January 7, 2021
• Study Completion: January 7, 2021
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

FR (1)