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

Scleral Thinning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05302609
• Other study ID #: SclerFIX-TBF3
• Secondary ID: 2021-A02109-32
• Status: Recruiting
• Phase: Phase 2
• Start date: July 4, 2022
• Est. completion date: July 2024

Study information

• Verified date: September 2023
• Source: TBF Genie Tissulaire
• Contact: Laurence BARNOUIN, MD
• Phone: 4 72 68 69 09
• Email: laurence.barnouin[@]tbf-lab.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Scleral Thinning

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital de la Croix-Rousse, Hospices Civils de Lyon	Lyon
France	Hôpital Pasteur 2 - CHU de NICE	Nice

Sponsors (1)

Lead Sponsor	Collaborator
TBF Genie Tissulaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Evaluation of the visual acuity	Scoring of blurred and poor vision (0: never, 4: all the time)	15 days, 1 month, 3 months
Secondary	Evaluation of the eye pressure	Measure of eye pressure using a tonometer	15 days, 1 month, 3 months