Corneal UlcerPhase 2NCT05172349
Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Trophic Ulcers
A Phase 2 study testing LV-Visio-AMTRIX in people with Corneal Ulcer and Persistent Corneal Epithelial Defect, run by TBF Genie Tissulaire.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Corneal Ulcer, Persistent Corneal Epithelial Defect
- What is being tested?
- LV-Visio-AMTRIX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
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
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.
- Being tested
- LV-Visio-AMTRIX
- Medical subject headings
- Corneal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LV-Visio-AMTRIXBiological
Chemically-treated, viro-inactivated, freeze-dried and irradiated allograft placed by the investigator during patients' hospital visit
| Study group | Role | What they receive |
|---|---|---|
| LV-Visio-AMTRIX | Experimental | Sutureless amniotic membrane supported by a biological ring positioned by the investigator during patients' hospital visits. Receives: Biological: LV-Visio-AMTRIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Largest diameter of persistent epithelial lesion area or corneal ulcer under 0.5 mm
Diameter assessed by centralized reading on photograph after fluorescein test
Measured: 15 days
Secondary outcomes (3)
Recovery of the visual acuity evaluated by Monoyer chart
Measured: 30 days, 45 days
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.
Measured: 2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days
Stabilisation or decrease of pain evaluated on visual analog scale
VAS on 10 points from 0: no pain to 10: worst imaginable pain
Measured: 2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study startApr 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: Change in sponsor's strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- TBF Genie Tissulaire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172349
- Sponsor's protocol ID
- L-Visio-AMTRIX-TBF4
- Other IDs
- IDRCB
- Status last verified
- Aug 2022
- First submitted
- 7 Dec 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05172349
- Acronym / sponsor ID
- L-Visio-AMTRIX-TBF4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in sponsor's strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TBF Genie TissulaireIndustry (pharma, biotech, devices)
- Study start
- Apr 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LV-Visio-AMTRIX | Experimental | Biological: LV-Visio-AMTRIXSutureless amniotic membrane supported by a biological ring positioned by the investigator during patients' hospital visits. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LV-Visio-AMTRIXChemically-treated, viro-inactivated, freeze-dried and irradiated allograft placed by the investigator during patients' hospital visit | Biological | LV-Visio-AMTRIX |
Primary outcome
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
3 secondary outcomes
Recovery of the visual acuity evaluated by Monoyer chart
Time frame: 30 days, 45 days
Stable or decreased score for inflammatory and clinical signs of the ocular surface
Time frame: 2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days
Stabilisation or decrease of pain evaluated on visual analog scale
Time frame: 2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LV-Visio-AMTRIX in people with Corneal Ulcer and Persistent Corneal Epithelial Defect, run by TBF Genie Tissulaire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Largest diameter of persistent epithelial lesion area or corneal ulcer under 0.5 mm (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.