Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole

Phase 2

Terminated

• Conditions: Macular Holes; Retinal Detachment
• Interventions: Biological: Visio-AMTRIX

• Registration Number: NCT05191628
• Lead Sponsor: TBF Genie Tissulaire

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-10
• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-13
• Primary Completion: 2022-10-10
• Study Completion: 2022-10-10
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Visio-AMTRIX	Visio-AMTRIX	Disk of amniotic membrane apposed or buried on recurrent macular hole by the Investigator after vitrectomy and fluid-gas exchange.

Primary Outcome Measures

Name	Time	Method
Closure of recurrent macular hole	6 months	Macular hole closure evaluated by optical coherence tomography (OCT)

Secondary Outcome Measures

Name	Time	Method
Functional restoration after closure of the macular hole	7 days, 15 days, 1 month, 3 months, 6 months	Best corrected visual acuity (BCVA) and microperimetry assessment
Evaluation of the surgical technique of placing the membrane	7 days, 15 days, 1 month, 3 months, 6 months	Duration of coverage by Visio-AMTRIX and persistent after gas removal
Absence of adverse reaction	7 days, 15 days, 1 month, 3 months, 6 months	Analysis of all adverse events and comparison with adverse events observed after vitrectomy
Anatomical restoration	1 month, 3 months, 6 months	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

Trial Locations

Locations (1)

Hôpital de la Croix-Rousse, Hospices Civils de Lyon; 🇫🇷 Lyon, France