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

NCT05302609 | Terminated Phase 2 DMC

• 2 other identifiers: SclerFIX-TBF32021-A02109-32
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Scleral Thinning

Keywords

Ocular Oncology; Tumor Exeresis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Absence of inflammatory reactions and good local tolerance of the implant

  15 days, 1 month, 3 months

• Evaluation of the visual acuity

  15 days, 1 month, 3 months

• Evaluation of the eye pressure

  15 days, 1 month, 3 months

Study Arms (1)

SclerFIX

EXPERIMENTAL

Patch of umbilical cord lining membrane sutured on top of the scleral defect.

Biological: SclerFIX

Interventions

SclerFIX BIOLOGICAL

Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in reinforcement of scleral thinning.

SclerFIX

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TBF Genie Tissulaire: lead

Study Sites (2)

Hôpital de la Croix-Rousse, Hospices Civils de Lyon

Lyon, 69004, France

Location

Hôpital Pasteur 2 - CHU de NICE

Nice, 06000, France

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: July 4, 2022
• Primary Completion: February 21, 2024
• Study Completion: February 21, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)