Clinical trial · Interventional
Evaluation of SclerFIX Graft in Scleral Thinning After Exeresis of Tumors of the Ocular Surface
Phase II Study: Evaluation of SclerFIX Graft in Scleral Thinning After Exeresis of Tumors of the Ocular Surface
NCT05302609CI-TRIAL-00082564terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual rate
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Scleral Thinning | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SclerFIX | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SclerFIX
- description
- Patch of umbilical cord lining membrane sutured on top of the scleral defect.
- interventionNames
- Biological: SclerFIX
Primary outcomes (1)
- measure
- Rate of tectonic success of the graft at 3 months
- timeFrame
- 3 months
- description
- 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).
Secondary outcomes (3)
- measure
- Absence of inflammatory reactions and good local tolerance of the implant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.