Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole

Retinal Detachment Clinical Trial

Official title:

Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05191628
• Other study ID #: Visio-AMTRIX-TMA-TBF
• Secondary ID: 2019-A01374-53
• Status: Terminated
• Phase: Phase 2
• Start date: June 10, 2020
• Est. completion date: October 10, 2022

Study information

• Verified date: April 2023
• Source: TBF Genie Tissulaire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: October 10, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Macular Holes
• Retinal Detachment
• Retinal Perforations

Intervention

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

Locations

Country	Name	City	State
France	Hôpital de la Croix-Rousse, Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
TBF Genie Tissulaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Closure of recurrent macular hole	Macular hole closure evaluated by optical coherence tomography (OCT)	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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