Scleral ThinningPhase 2NCT05302609
Evaluation of SclerFIX Graft in Scleral Thinning After Exeresis of Tumors of the Ocular Surface
A Phase 2 study testing SclerFIX in people with Scleral Thinning, run by TBF Genie Tissulaire at 2 sites in France.
Trial summary
The purpose of this open, multicenter phase II trial is to confirm the tolerance and evaluate the efficacy of the SclerFIX product, an allograft of umbilical cord lining membrane, in reinforcement of scleral thinning in patients who underwent eye tumor exeresis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Scleral Thinning
- What is being tested?
- SclerFIX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Jul 2022to 21 Feb 2024
- 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, aged 18 to 80 years.
- Patients with risk of perforation or deep loss of substance during surgical removal of a tumor of the ocular surface.
- Patient with loss of substance < 3cm2.
- Patient able to understand, sign and date the informed consent form.
- Patient who is a member or a beneficiary of a national health insurance plan.
Who cannot join
- Pregnant or breastfeeding woman or woman of childbearing age without effective contraception.
- Patients with uncontrolled infectious risk.
- Patient with an autoimmune disease.
- Person deprived of liberty by a judicial or administrative decision.
- Person under forced psychiatric care.
- Person admitted to a health or social institution for purposes other than the research.
- Adult subjected to a legal protection measure or unable to express his / her consent.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, 69004
Hôpital Pasteur 2 - CHU de NICE
Nice, 06000
About this study
Official title: Phase II Study: Evaluation of SclerFIX Graft in Scleral Thinning After Exeresis of Tumors of the Ocular Surface
The purpose of this open, multicenter phase II trial is to confirm the tolerance and evaluate the efficacy of the SclerFIX product, an allograft of umbilical cord lining membrane, in reinforcement of scleral thinning in patients who underwent eye tumor exeresis.
Read the detailed description
As scleral graft is forbidden in France, it cannot be used to reinforce the sclera. This study investigational product, SclerFIX, was developed to substitute scleral grafts.
- Conditions
- Scleral Thinning
- Being tested
- SclerFIX
- Keywords
- Ocular Oncology, Tumor Exeresis
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 reinforcement of scleral thinning.
| Study group | Role | What they receive |
|---|---|---|
| SclerFIX | Experimental | Patch of umbilical cord lining membrane sutured on top of the scleral defect. Receives: Biological: SclerFIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of tectonic success of the graft at 3 months
The graft will be considered successful at 3 months if the curvature of the eye is respected without thinning, i.e., in the absence of edema, ulceration and loss of substance (thickness of the grafted area/thickness of the adjacent surface > 80%). The scleral thickness will be determined from images obtained by optical coherence tomography (OCT).
Measured: 3 months
Secondary outcomes (3)
Absence of inflammatory reactions and good local tolerance of the implant
Composite score evaluating the presence of local reactions (edema, redness, vascularization, discharge) and of ulceration, pain and foreign body sensation (0: excellent local tolerance, 46: worst possible local tolerance)
Measured: 15 days, 1 month, 3 months
Evaluation of the visual acuity
Scoring of blurred and poor vision (0: never, 4: all the time)
Measured: 15 days, 1 month, 3 months
Evaluation of the eye pressure
Measure of eye pressure using a tonometer
Measured: 15 days, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start4 Jul 2022
- Primary completion21 Feb 2024
- Study completion21 Feb 2024
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 Scleral ThinningStudies 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
- 17 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
- NCT05302609
- Sponsor's protocol ID
- SclerFIX-TBF3
- Other IDs
- 2021-A02109-32
- Status last verified
- Nov 2024
- First submitted
- 21 Mar 2022
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study: Evaluation of SclerFIX Graft in Scleral Thinning After Exeresis of Tumors of the Ocular Surface
- ClinicalTrials.gov ID
- NCT05302609
- Acronym / sponsor ID
- SclerFIX-TBF3
- Conditions
- Scleral Thinning
- Keywords
- Ocular Oncology, Tumor Exeresis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual rate
- Enrolment
- 17 participants (actual)
- Lead sponsor
- TBF Genie TissulaireIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 31 Mar 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 phase II trial is to confirm the tolerance and evaluate the efficacy of the SclerFIX product, an allograft of umbilical cord lining membrane, in reinforcement of scleral thinning in patients who underwent eye tumor exeresis.
Detailed description
As scleral graft is forbidden in France, it cannot be used to reinforce the sclera. This study investigational product, SclerFIX, was developed to substitute scleral grafts.
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: SclerFIXPatch of umbilical cord lining membrane sutured on top of the scleral defect. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, aged 18 to 80 years.
- Patients with risk of perforation or deep loss of substance during surgical removal of a tumor of the ocular surface.
- Patient with loss of substance < 3cm2.
- Patient able to understand, sign and date the informed consent form.
- Patient who is a member or a beneficiary of a national health insurance plan.
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding woman or woman of childbearing age without effective contraception.
- Patients with uncontrolled infectious risk.
- Patient with an autoimmune disease.
- Person deprived of liberty by a judicial or administrative decision.
- Person under forced psychiatric care.
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 reinforcement of scleral thinning. | Biological | SclerFIX |
Primary outcome
Rate of tectonic success of the graft at 3 months
Time frame: 3 months
The graft will be considered successful at 3 months if the curvature of the eye is respected without thinning, i.e., in the absence of edema, ulceration and loss of substance (thickness of the grafted area/thickness of the adjacent surface > 80%). The scleral thickness will be determined from images obtained by optical coherence tomography (OCT).
3 secondary outcomes
Absence of inflammatory reactions and good local tolerance of the implant
Time frame: 15 days, 1 month, 3 months
Evaluation of the visual acuity
Time frame: 15 days, 1 month, 3 months
Evaluation of the eye pressure
Time frame: 15 days, 1 month, 3 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 14 Nov 2024.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SclerFIX in people with Scleral Thinning, run by TBF Genie Tissulaire at 2 sites 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 5 inclusion and 7 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 2 sites 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?
Rate of tectonic success of the graft at 3 months (time frame: 3 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 14 Nov 2024.