Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole

TBF Genie Tissulaire

Status and phase

Terminated

Phase 2

Conditions

Retinal Detachment

Macular Holes

Treatments

Biological: Visio-AMTRIX

Study type

Interventional

Funder types

Industry

Identifiers

NCT05191628

Visio-AMTRIX-TMA-TBF

2019-A01374-53 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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