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

Phase 1

Completed

• Conditions: Enucleated; Eye; Eye Cancer
• Interventions: Biological: SclerFIX

• Registration Number: NCT05236049
• Lead Sponsor: TBF Genie Tissulaire

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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-11
• Primary Completion: 2022-04-27
• Study Completion: 2022-04-27
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SclerFIX	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.

Primary Outcome Measures

Name	Time	Method
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)	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

Secondary Outcome Measures

Name	Time	Method
Rate of integration of SclerFIX set-up in the orbital cavity with muscles attachment allowing enucleation implant mobility	7 days, 15 days, 1 month, 3 months, 6 months	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
Evaluation of surgical wrapping and attachment with muscles	Time of investigational product surgical implantation (Day 0)	Surgeon assessment on completeness and difficulty of oculomotor muscles insertion at the time of product implantation (Day 0)

Trial Locations

Locations (1)

Institut Curie; 🇫🇷 Paris, France