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

NCT05236049 | Completed Phase 1

• 2 other identifiers: SclerFIX-TBF12018-A01738-47
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Enucleated; Eye; Eye Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 of surgical wrapping and attachment with muscles

  Time of investigational product surgical implantation (Day 0)

Study Arms (1)

SclerFIX

EXPERIMENTAL

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

Interventions

SclerFIX BIOLOGICAL

Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in support of intraocular implant.

SclerFIX

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TBF Genie Tissulaire: lead

Study Sites (1)

Institut Curie

Paris, 75005, France

Location

MeSH Terms

Conditions

Eye Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: February 11, 2022
• Study Start: July 1, 2019
• Primary Completion: April 27, 2022
• Study Completion: April 27, 2022
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)