KeratitisPhase 2NCT05250583
Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Treatment-Resistant Keratitis
A Phase 2 study testing LV-Visio-AMTRIX in people with Keratitis, run by TBF Genie Tissulaire at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Keratitis
- What is being tested?
- LV-Visio-AMTRIX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2020to 7 Jan 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- LV-Visio-AMTRIX
- Medical subject headings
- Keratitis
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. Receives: Biological: LV-Visio-AMTRIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 days
Secondary outcomes (4)
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: 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
Visual Analog Scale (VAS) on 10 points from 0: no pain to 10: worst imaginable pain
Measured: 1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days
Preservation of epithelialization
Preservation of new epithelialization evaluated under slit lamp using fluorescein instillation and Oxford grading system
Measured: 15 days, 30 days, 45 days
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)
Measured: 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 posted22 Feb 2022
- Study start29 Jun 2020
- Primary completion7 Jan 2021
- Study completion7 Jan 2021
Why it stopped: Low accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratitisStudies 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
- 5 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
- NCT05250583
- Sponsor's protocol ID
- L-Visio-AMTRIX-TBF3
- Other IDs
- 2019-A03144-53
- Status last verified
- Nov 2024
- First submitted
- 10 Feb 2022
- Last updated
- 14 Nov 2024
- 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 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05250583
- Acronym / sponsor ID
- L-Visio-AMTRIX-TBF3
- Conditions
- Keratitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual rate
- Enrolment
- 5 participants (actual)
- Lead sponsor
- TBF Genie TissulaireIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- 7 Jan 2021 (actual)
- First posted
- 22 Feb 2022 (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, 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.
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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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
Keratitis healing within 15 days after the beginning of the treatment
Time frame: 15 days
Keratitis observed under slit lamp using fluorescein instillation. Keratitis considered healed if epithelialization of more than 50% and/or Oxford < grade 2
4 secondary outcomes
Stable or decreased score for inflammatory and clinical signs of the ocular surface
Time frame: 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
Time frame: 1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days
Preservation of epithelialization
Time frame: 15 days, 30 days, 45 days
Change in eye dryness
Time frame: 15 days, 30 days, 45 days
Results and safety
The study was stopped early (reason given: Low accrual rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LV-Visio-AMTRIX in people with Keratitis, run by TBF Genie Tissulaire at 1 site in France.
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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Low accrual rate). Results are not available in the source record.
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?
Keratitis healing within 15 days after the beginning of the treatment (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 14 Nov 2024.