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

TBF Genie Tissulaire

Status and phase: Completed; Phase 1

Conditions: Eye Cancer; Enucleated; Eye

Treatments: Biological: SclerFIX

Study type: Interventional

Funder types: Industry

Identifiers

NCT05236049

2018-A01738-47 (Registry Identifier)

SclerFIX-TBF1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

SclerFIX

Experimental group

Description:

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.

Treatment:

Biological: SclerFIX