Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant

NCT ID: NCT05236049

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2022-04-27

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SclerFIX

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.

Group Type: EXPERIMENTAL

SclerFIX

Intervention Type: BIOLOGICAL

Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in support of intraocular implant.

Interventions

SclerFIX

Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in support of intraocular implant.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TBF Genie Tissulaire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Curie

Paris, , France

Countries

France

Other Identifiers

2018-A01738-47

Identifier Type: REGISTRY

Identifier Source: secondary_id

SclerFIX-TBF1

Identifier Type: -

Identifier Source: org_study_id