Status:
TERMINATED
Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole
Lead Sponsor:
TBF Genie Tissulaire
Conditions:
Macular Holes
Retinal Detachment
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 previo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05191628
Start Date
June 10 2020
End Date
October 10 2022
Last Update
May 1 2023
Active Locations (1)
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1
Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, France, 69004