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

Phase II Study: Evaluation of SclerFIX Graft in Scleral Thinning After Exeresis of Tumors of the Ocular Surface

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.

Study Overview

• Status: Terminated
• Conditions: Scleral Thinning
• Intervention / Treatment: Biological: SclerFIX

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hôpital de la Croix-Rousse, Hospices Civils de Lyon
  • Nice, France, 06000
    • Hôpital Pasteur 2 - CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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; Patch of umbilical cord lining membrane sutured on top of the scleral defect.	Biological: SclerFIX; Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in reinforcement of scleral thinning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of tectonic success of the graft at 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).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of inflammatory reactions and good local tolerance of the implant	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)	15 days, 1 month, 3 months
Evaluation of the visual acuity	Scoring of blurred and poor vision (0: never, 4: all the time)	15 days, 1 month, 3 months
Evaluation of the eye pressure	Measure of eye pressure using a tonometer	15 days, 1 month, 3 months

Collaborators and Investigators

• Sponsor: TBF Genie Tissulaire

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Actual): February 21, 2024
• Study Completion (Actual): February 21, 2024

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Ocular Oncology; Tumor Exeresis
• Other Study ID Numbers: SclerFIX-TBF3; 2021-A02109-32 (Other 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
• product manufactured in and exported from the U.S.: No