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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Scleral Thinning

Intervention / Treatment
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* Biological: SclerFIX


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SclerFIX<br>Patch of umbilical cord lining membrane sutured on top of the scleral defect. | Biological: SclerFIX<br>* Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in reinforcement of scleral thinning.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular Oncology, Tumor Exeresis