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

Keratitis Clinical Trial

Official title:

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 Keratitis Resisting Healing Medical Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05250583
• Other study ID #: L-Visio-AMTRIX-TBF3
• Secondary ID: 2019-A03144-53
• Status: Terminated
• Phase: Phase 2
• Start date: June 29, 2020
• Est. completion date: January 7, 2021

Study information

• Verified date: June 2022
• Source: TBF Genie Tissulaire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 7, 2021
• Est. primary completion date: January 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• Ocular surgery in the 3 months preceding the inclusion in the study.

• 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.

Related Conditions & MeSH terms

• Keratitis

Intervention

Biological:
• LV-Visio-AMTRIX
Chemically-treated, viro-inactivated, freeze-dried and irradiated allograft placed by the investigator during patients' hospital visit

Locations

Country	Name	City	State
France	CHU de Saint-Etienne Hôpital Nord	Saint-Priest-en-Jarez

Sponsors (1)

Lead Sponsor	Collaborator
TBF Genie Tissulaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stable or decreased score for inflammatory and clinical signs of the ocular surface	Composite score for inflammatory and clinical signs of the ocular surface on 66 points. Duration and intensity are evaluated for secretion, dry eyes, tearing, foreign body sensation, fluctuating vision, photophobia, burning sensation and lids edema. Duration is evaluated from a scale from 0: never to 4: all the time. Intensity is evaluated from a scale from 0: slight to 2: severe. Localization and intensity are evaluated for conjunctival edema, conjunctival redness and neovascularization. Localization is evaluated on a scale from 0: no reaction to 4: reaction present in the whole eye.	1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days
Secondary	Stabilisation or decrease of pain evaluated on visual analog scale	Visual Analog Scale (VAS) on 10 points from 0: no pain to 10: worst imaginable pain	1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days
Secondary	Preservation of epithelialization	Preservation of new epithelialization evaluated under slit lamp using fluorescein instillation and Oxford grading system	15 days, 30 days, 45 days
Secondary	Change in eye dryness	Eye dryness evaluated by the Ocular Surface Disease Index (OSDI) (0-12 = normal; 13-22 = mild dry eye; 23-32 = moderate dry eye; >33 = severe dry eye)	15 days, 30 days, 45 days