Clinical trial

Evaluation of Safety and Efficacy of Wrapping Orbital Implant by SclerFIX Product After Eye Enucleation

Name

SclerFIX-TBF1

Description

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.

Trial arms

Trial start

2019-07-01

Estimated PCD

2022-04-27

Trial end

2022-04-27

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

SclerFIX

Size

Primary endpoint

Number of complications and adverse events related to SclerFIX set-up as replacement of sclera graft for support of enucleation implant

Through study completion (6 months)

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}

Updated at

2023-05-01

1 organization

1 product

2 indications

Organization

Product

Indication

Indication