Macular HolesPhase 2NCT05191628
Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole
A Phase 2 study testing Visio-AMTRIX in people with Macular Holes and Retinal Detachment, run by TBF Genie Tissulaire at 1 site in France.
Trial summary
The purpose of this open, multicenter trial is to assess the impact of the use of an amniotic membrane graft on the closure of macular hole-associated retinal detachment in patients with failed previous macular surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Macular Holes, Retinal Detachment
- What is being tested?
- Visio-AMTRIX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2020to 10 Oct 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman over 18 years of age, less than 75 years
- Macular Hole of all etiologies
- Patient with history of opened macular hole after previous pars plana vitrectomy
- Delay between previous surgery and inclusion (relapse or non-closing hole) > 1 month
- Patient who received the study information and provided consent
- Patient who is a members or a beneficiary of a national health insurance plan
Who cannot join
- Ocular surgery other than the macular hole surgery in the prior 3 months
- Participation in other clinical studies in the prior 3 months
- Any current or prior ocular pathology that could interfere with the conduct of the study, including visually significant cataract or media opacity
- Patient with uncontrolled glaucoma on more than 1 intraocular lowering medication
- Patient with uveitis or other active ocular inflammation or infection
- Pregnant or breast-feeding woman. Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study or to use an effective birth control method
- Person deprived of liberty by judicial or administrative measures
- Any other reason which in the opinion of the investigator would preclude the adherence of the schedules visits, safe participation in the study or affect the results of the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this open, multicenter trial is to assess the impact of the use of an amniotic membrane graft on the closure of macular hole-associated retinal detachment in patients with failed previous macular surgery.
- Conditions
- Macular Holes, Retinal Detachment
- Being tested
- Visio-AMTRIX
- Medical subject headings
- Retinal Perforations, Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visio-AMTRIXBiological
Chemically-treated, viro-inactivated, freeze-dried and irradiated amniotic membrane placed by the investigator during macular hole surgery
| Study group | Role | What they receive |
|---|---|---|
| Visio-AMTRIX | Experimental | Disk of amniotic membrane apposed or buried on recurrent macular hole by the Investigator after vitrectomy and fluid-gas exchange. Receives: Biological: Visio-AMTRIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of recurrent macular hole
Macular hole closure evaluated by optical coherence tomography (OCT)
Measured: 6 months
Secondary outcomes (4)
Absence of adverse reaction
Analysis of all adverse events and comparison with adverse events observed after vitrectomy
Measured: 7 days, 15 days, 1 month, 3 months, 6 months
Functional restoration after closure of the macular hole
Best corrected visual acuity (BCVA) and microperimetry assessment
Measured: 7 days, 15 days, 1 month, 3 months, 6 months
Anatomical restoration
Anatomical restoration of the outer segments (external limiting membrane and ellipsoid layer). Anatomical changes in the ganglion cell layer of the retina in the area around the hole and under the membrane. The assessment is done by OCT measuring the thickness of the ganglion cell layer
Measured: 1 month, 3 months, 6 months
Evaluation of the surgical technique of placing the membrane
Duration of coverage by Visio-AMTRIX and persistent after gas removal
Measured: 7 days, 15 days, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start10 Jun 2020
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
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 Macular HolesStudies 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
- 12 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
- NCT05191628
- Sponsor's protocol ID
- Visio-AMTRIX-TMA-TBF
- Other IDs
- 2019-A01374-53
- Status last verified
- Apr 2023
- First submitted
- 29 Dec 2021
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole
- ClinicalTrials.gov ID
- NCT05191628
- Acronym / sponsor ID
- Visio-AMTRIX-TMA-TBF
- Conditions
- Macular Holes, Retinal Detachment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual rate
- Enrolment
- 12 participants (actual)
- Lead sponsor
- TBF Genie TissulaireIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 13 Jan 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, multicenter trial is to assess the impact of the use of an amniotic membrane graft on the closure of macular hole-associated retinal detachment in patients with failed previous macular surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visio-AMTRIX | Experimental | Biological: Visio-AMTRIXDisk of amniotic membrane apposed or buried on recurrent macular hole by the Investigator after vitrectomy and fluid-gas exchange. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Man or woman over 18 years of age, less than 75 years
- Macular Hole of all etiologies
- Patient with history of opened macular hole after previous pars plana vitrectomy
- Delay between previous surgery and inclusion (relapse or non-closing hole) > 1 month
- Patient who received the study information and provided consent
Key exclusion criteria (8 listed)
- Ocular surgery other than the macular hole surgery in the prior 3 months
- Participation in other clinical studies in the prior 3 months
- Any current or prior ocular pathology that could interfere with the conduct of the study, including visually significant cataract or media opacity
- Patient with uncontrolled glaucoma on more than 1 intraocular lowering medication
- Patient with uveitis or other active ocular inflammation or infection
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 |
|---|---|---|
| Visio-AMTRIXChemically-treated, viro-inactivated, freeze-dried and irradiated amniotic membrane placed by the investigator during macular hole surgery | Biological | Visio-AMTRIX |
Primary outcome
Closure of recurrent macular hole
Time frame: 6 months
Macular hole closure evaluated by optical coherence tomography (OCT)
4 secondary outcomes
Absence of adverse reaction
Time frame: 7 days, 15 days, 1 month, 3 months, 6 months
Functional restoration after closure of the macular hole
Time frame: 7 days, 15 days, 1 month, 3 months, 6 months
Anatomical restoration
Time frame: 1 month, 3 months, 6 months
Evaluation of the surgical technique of placing the membrane
Time frame: 7 days, 15 days, 1 month, 3 months, 6 months
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 1 May 2023.
- Individual participant dataSharing planned: No
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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 Visio-AMTRIX in people with Macular Holes and Retinal Detachment, 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 8 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 1 May 2023. 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?
Closure of recurrent macular hole (time frame: 6 months). 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 1 May 2023.