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

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

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.

Study Overview

• Status: Completed
• Conditions: Enucleated; Eye; Eye Cancer
• Intervention / Treatment: Biological: SclerFIX

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Paris, France, 75005
    • Institut Curie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)

Collaborators and Investigators

• Sponsor: TBF Genie Tissulaire

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): April 27, 2022
• Study Completion (Actual): April 27, 2022

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Eye Diseases; Eye Neoplasms
• Other Study ID Numbers: SclerFIX-TBF1; 2018-A01738-47 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No