Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole

The purpose of this open, multicenter trial is to assess the impact of the use of an amniotic membrane graft on the closure of macular hole-associated retinal detachment in patients with failed previous macular surgery.

Study Overview

• Status: Terminated
• Conditions: Retinal Detachment; Macular Holes
• Intervention / Treatment: Biological: Visio-AMTRIX

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hôpital de la Croix-Rousse, Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Man or woman over 18 years of age, less than 75 years
• Macular Hole of all etiologies
• Patient with history of opened macular hole after previous pars plana vitrectomy
• Delay between previous surgery and inclusion (relapse or non-closing hole) > 1 month
• Patient who received the study information and provided consent
• Patient who is a members or a beneficiary of a national health insurance plan

Exclusion Criteria:

• Ocular surgery other than the macular hole surgery in the prior 3 months
• Participation in other clinical studies in the prior 3 months
• Any current or prior ocular pathology that could interfere with the conduct of the study, including visually significant cataract or media opacity
• Patient with uncontrolled glaucoma on more than 1 intraocular lowering medication
• Patient with uveitis or other active ocular inflammation or infection
• Pregnant or breast-feeding woman. Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study or to use an effective birth control method
• Person deprived of liberty by judicial or administrative measures
• Any other reason which in the opinion of the investigator would preclude the adherence of the schedules visits, safe participation in the study or affect the results of the study

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: Visio-AMTRIX; Disk of amniotic membrane apposed or buried on recurrent macular hole by the Investigator after vitrectomy and fluid-gas exchange.	Biological: Visio-AMTRIX; Chemically-treated, viro-inactivated, freeze-dried and irradiated amniotic membrane placed by the investigator during macular hole surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Closure of recurrent macular hole	Macular hole closure evaluated by optical coherence tomography (OCT)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of adverse reaction	Analysis of all adverse events and comparison with adverse events observed after vitrectomy	7 days, 15 days, 1 month, 3 months, 6 months
Functional restoration after closure of the macular hole	Best corrected visual acuity (BCVA) and microperimetry assessment	7 days, 15 days, 1 month, 3 months, 6 months
Anatomical restoration	Anatomical restoration of the outer segments (external limiting membrane and ellipsoid layer). Anatomical changes in the ganglion cell layer of the retina in the area around the hole and under the membrane. The assessment is done by OCT measuring the thickness of the ganglion cell layer	1 month, 3 months, 6 months
Evaluation of the surgical technique of placing the membrane	Duration of coverage by Visio-AMTRIX and persistent after gas removal	7 days, 15 days, 1 month, 3 months, 6 months

Collaborators and Investigators

• Sponsor: TBF Genie Tissulaire

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2020
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): October 10, 2022

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations; Retinal Detachment
• Other Study ID Numbers: Visio-AMTRIX-TMA-TBF; 2019-A01374-53 (Registry 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