Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole

Study Overview
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Brief Summary
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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.

Official Title
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Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole

Conditions
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Macular Holes, Retinal Detachment

Intervention / Treatment
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* Biological: Visio-AMTRIX


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Visio-AMTRIX<br>Disk of amniotic membrane apposed or buried on recurrent macular hole by the Investigator after vitrectomy and fluid-gas exchange. | Biological: Visio-AMTRIX<br>* Chemically-treated, viro-inactivated, freeze-dried and irradiated amniotic membrane placed by the investigator during macular hole surgery<br>|

What is the study measuring?
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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 |