Enucleated; EyePhase 1NCT05236049
Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant
A Phase 1 study testing SclerFIX in people with Enucleated; Eye and Eye Cancer, run by TBF Genie Tissulaire at 1 site in France.
Trial summary
The purpose of this open, monocenter pilot trial is to evaluate the tolerance of the SclerFIX product, an allograft of umbilical cord lining membrane, in the reinforcement of ocular implants in patients who underwent enucleation due to an eye malignant tumor resection. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Enucleated; Eye, Eye Cancer
- What is being tested?
- SclerFIX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 27 Apr 2022
- Phase
- Phase 1
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women between 45 and 85 years old, presenting an enucleation caused by malignant tumor resection.
- Oncological treatment compatibility with enucleation and intra-orbital implant.
- Surgery requiring the placement of an enucleation implant.
- Persistence of the oculomotor muscles allowing their insertion into the tissue.
- Patient with social security coverage.
- Consenting and informed patient.
Who cannot join
- Pregnant or breast-feeding women: women of childbearing age were asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method.
- Patient presenting an infectious risk (neutropenia, active local infection, immunodeficiency).
- Patient with autoimmune disease.
- Proton-therapy / radiotherapy of the eye before healing.
- Patient with oculomotor muscles invasion or non-attachment of these muscles.
- Allergy to contrast agents used in radiology.
- Patient under legal guardianship.
- Patient not benefiting from the social security cover.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Safety and Efficacy of Wrapping Orbital Implant by SclerFIX Product After Eye Enucleation
The purpose of this open, monocenter pilot trial is to evaluate the tolerance of the SclerFIX product, an allograft of umbilical cord lining membrane, in the reinforcement of ocular implants in patients who underwent enucleation due to an eye malignant tumor resection.
Read the detailed description
As scleral graft is forbidden in France, it cannot be used for support of enucleation implants. This study investigational product, SclerFIX, was developed to substitute scleral grafts in those cases.
- Conditions
- Enucleated; Eye, Eye Cancer
- Being tested
- SclerFIX
- Medical subject headings
- Eye Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SclerFIXBiological
Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in support of intraocular implant.
| Study group | Role | What they receive |
|---|---|---|
| SclerFIX | Experimental | Strip of umbilical cord lining membrane allograft wrapped around the bioceramic enucleation implant. The assembly is placed inside the void orbital cavity and the muscles are sutured to the SclerFIX strips. Receives: Biological: SclerFIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of complications and adverse events related to SclerFIX set-up as replacement of sclera graft for support of enucleation implant
Evaluation of SclerFIX tolerance by physical examination of the patient: clean scar; absence of redness, edema, ulcer, granuloma and cystic lesion; absence of signs of protrusion and inflammation
Measured: Through study completion (6 months)
Secondary outcomes (2)
Rate of integration of SclerFIX set-up in the orbital cavity with muscles attachment allowing enucleation implant mobility
Evaluation by physical examination by the surgeon of the set-up assembly and its maintenance over time with insertion of oculomotor muscles, integration of these latter, and maintenance of the movement of the implant
Measured: 7 days, 15 days, 1 month, 3 months, 6 months
Evaluation of surgical wrapping and attachment with muscles
Surgeon assessment on completeness and difficulty of oculomotor muscles insertion at the time of product implantation (Day 0)
Measured: Time of investigational product surgical implantation (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Jul 2019
- Primary completion27 Apr 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enucleated; EyeStudies 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 1
- 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
- NCT05236049
- Sponsor's protocol ID
- SclerFIX-TBF1
- Other IDs
- 2018-A01738-47
- Status last verified
- Apr 2023
- First submitted
- 3 Jan 2022
- 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
- Evaluation of Safety and Efficacy of Wrapping Orbital Implant by SclerFIX Product After Eye Enucleation
- ClinicalTrials.gov ID
- NCT05236049
- Acronym / sponsor ID
- SclerFIX-TBF1
- Conditions
- Enucleated; Eye, Eye Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- TBF Genie TissulaireIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 11 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, monocenter pilot trial is to evaluate the tolerance of the SclerFIX product, an allograft of umbilical cord lining membrane, in the reinforcement of ocular implants in patients who underwent enucleation due to an eye malignant tumor resection.
Detailed description
As scleral graft is forbidden in France, it cannot be used for support of enucleation implants. This study investigational product, SclerFIX, was developed to substitute scleral grafts in those cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SclerFIX | Experimental | Biological: SclerFIXStrip of umbilical cord lining membrane allograft wrapped around the bioceramic enucleation implant. The assembly is placed inside the void orbital cavity and the muscles are sutured to the SclerFIX strips. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women between 45 and 85 years old, presenting an enucleation caused by malignant tumor resection.
- Oncological treatment compatibility with enucleation and intra-orbital implant.
- Surgery requiring the placement of an enucleation implant.
- Persistence of the oculomotor muscles allowing their insertion into the tissue.
- Patient with social security coverage.
Key exclusion criteria (8 listed)
- Pregnant or breast-feeding women: women of childbearing age were asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method.
- Patient presenting an infectious risk (neutropenia, active local infection, immunodeficiency).
- Patient with autoimmune disease.
- Proton-therapy / radiotherapy of the eye before healing.
- Patient with oculomotor muscles invasion or non-attachment of these muscles.
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 |
|---|---|---|
| SclerFIXChemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in support of intraocular implant. | Biological | SclerFIX |
Primary outcome
Number of complications and adverse events related to SclerFIX set-up as replacement of sclera graft for support of enucleation implant
Time frame: Through study completion (6 months)
Evaluation of SclerFIX tolerance by physical examination of the patient: clean scar; absence of redness, edema, ulcer, granuloma and cystic lesion; absence of signs of protrusion and inflammation
2 secondary outcomes
Rate of integration of SclerFIX set-up in the orbital cavity with muscles attachment allowing enucleation implant mobility
Time frame: 7 days, 15 days, 1 month, 3 months, 6 months
Evaluation of surgical wrapping and attachment with muscles
Time frame: Time of investigational product surgical implantation (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 1 study testing SclerFIX in people with Enucleated; Eye and Eye Cancer, 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: finished, 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of complications and adverse events related to SclerFIX set-up as replacement of sclera graft for support of enucleation implant (time frame: Through study completion (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.