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

Phase 2

Terminated

• Conditions: Scleral Thinning
• Interventions: Biological: SclerFIX

• Registration Number: NCT05302609
• Lead Sponsor: TBF Genie Tissulaire

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-31
• Study Start: 2022-07-04
• Primary Completion: 2024-02-21
• Study Completion: 2024-02-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SclerFIX	SclerFIX	Patch of umbilical cord lining membrane sutured on top of the scleral defect.

Primary Outcome Measures

Name	Time	Method
Rate of tectonic success of the graft at 3 months	3 months	The graft will be considered successful at 3 months if the curvature of the eye is respected without thinning, i.e., in the absence of edema, ulceration and loss of substance (thickness of the grafted area/thickness of the adjacent surface \> 80%). The scleral thickness will be determined from images obtained by optical coherence tomography (OCT).

Secondary Outcome Measures

Name	Time	Method
Evaluation of the eye pressure	15 days, 1 month, 3 months	Measure of eye pressure using a tonometer
Absence of inflammatory reactions and good local tolerance of the implant	15 days, 1 month, 3 months	Composite score evaluating the presence of local reactions (edema, redness, vascularization, discharge) and of ulceration, pain and foreign body sensation (0: excellent local tolerance, 46: worst possible local tolerance)
Evaluation of the visual acuity	15 days, 1 month, 3 months	Scoring of blurred and poor vision (0: never, 4: all the time)

Trial Locations

Locations (2)

Hôpital de la Croix-Rousse, Hospices Civils de Lyon; 🇫🇷 Lyon, France

Hôpital Pasteur 2 - CHU de NICE; 🇫🇷 Nice, France