Evaluation of SclerFIX Graft in Scleral Thinning After Exeresis of Tumors of the Ocular Surface

TBF Genie Tissulaire

Status and phase

Terminated

Phase 2

Conditions

Scleral Thinning

Treatments

Biological: SclerFIX

Study type

Interventional

Funder types

Industry

Identifiers

NCT05302609

SclerFIX-TBF3

2021-A02109-32 (Other Identifier)

Details and patient eligibility

About

The purpose of this open, multicenter phase II trial is to confirm the tolerance and evaluate the efficacy of the SclerFIX product, an allograft of umbilical cord lining membrane, in reinforcement of scleral thinning in patients who underwent eye tumor exeresis.

Full description

As scleral graft is forbidden in France, it cannot be used to reinforce the sclera. This study investigational product, SclerFIX, was developed to substitute scleral grafts.

Enrollment

17 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female, aged 18 to 80 years.
Patients with risk of perforation or deep loss of substance during surgical removal of a tumor of the ocular surface.
Patient with loss of substance < 3cm2.
Patient able to understand, sign and date the informed consent form.
Patient who is a member or a beneficiary of a national health insurance plan.

Exclusion criteria

Pregnant or breastfeeding woman or woman of childbearing age without effective contraception.
Patients with uncontrolled infectious risk.
Patient with an autoimmune disease.
Person deprived of liberty by a judicial or administrative decision.
Person under forced psychiatric care.
Person admitted to a health or social institution for purposes other than the research.
Adult subjected to a legal protection measure or unable to express his / her consent.