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

Eye Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05236049
• Other study ID #: SclerFIX-TBF1
• Secondary ID: 2018-A01738-47
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2019
• Est. completion date: April 27, 2022

Study information

• Verified date: April 2023
• Source: TBF Genie Tissulaire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 27, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enucleated; Eye
• Eye Cancer
• Eye Neoplasms

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
France	Institut Curie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
TBF Genie Tissulaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of complications and adverse events related to SclerFIX set-up as replacement of sclera graft for support of enucleation implant	Evaluation of SclerFIX tolerance by physical examination of the patient: clean scar; absence of redness, edema, ulcer, granuloma and cystic lesion; absence of signs of protrusion and inflammation	Through study completion (6 months)
Secondary	Rate of integration of SclerFIX set-up in the orbital cavity with muscles attachment allowing enucleation implant mobility	Evaluation by physical examination by the surgeon of the set-up assembly and its maintenance over time with insertion of oculomotor muscles, integration of these latter, and maintenance of the movement of the implant	7 days, 15 days, 1 month, 3 months, 6 months
Secondary	Evaluation of surgical wrapping and attachment with muscles	Surgeon assessment on completeness and difficulty of oculomotor muscles insertion at the time of product implantation (Day 0)	Time of investigational product surgical implantation (Day 0)