Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole

NCT05191628 | Terminated Phase 2

• 2 other identifiers: Visio-AMTRIX-TMA-TBF2019-A01374-53
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Holes; Retinal Detachment

Outcome Measures

Primary Outcomes (1)

• Closure of recurrent macular hole

  Macular hole closure evaluated by optical coherence tomography (OCT)

  6 months

Secondary Outcomes (4)

• Absence of adverse reaction

  7 days, 15 days, 1 month, 3 months, 6 months

• Functional restoration after closure of the macular hole

  7 days, 15 days, 1 month, 3 months, 6 months

• Anatomical restoration

  1 month, 3 months, 6 months

• Evaluation of the surgical technique of placing the membrane

  7 days, 15 days, 1 month, 3 months, 6 months

Study Arms (1)

Visio-AMTRIX

EXPERIMENTAL

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

Biological: Visio-AMTRIX

Interventions

Visio-AMTRIX BIOLOGICAL

Chemically-treated, viro-inactivated, freeze-dried and irradiated amniotic membrane placed by the investigator during macular hole surgery

Visio-AMTRIX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patient who received the study information and provided consent
• Patient who is a members or a beneficiary of a national health insurance plan

You may not qualify if:

• 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

Sponsors & Collaborators

• TBF Genie Tissulaire: lead

Study Sites (1)

Hôpital de la Croix-Rousse, Hospices Civils de Lyon

Lyon, 69004, France

Location

MeSH Terms

Conditions

Retinal Perforations; Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

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: December 29, 2021
• First Posted: January 13, 2022
• Study Start: June 10, 2020
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)