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NCT Number: NCT05236049

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

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.

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Key information

Conditions

Enucleated; Eye Eye Cancer Eye Diseases Eye Neoplasms Neoplasms Neoplasms by Site

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institut Curie

Paris, 75005, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Rate of integration of SclerFIX set-up in the orbital cavity with muscles attachment allowing enucleation implant mobility

    Time frame: 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

  2. Evaluation of surgical wrapping and attachment with muscles

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

TBF Genie Tissulaire

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 11, 2022
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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