A Phase 2 interventional study of Visio-AMTRIX in Macular Holes and Retinal Detachment, sponsored by TBF Genie Tissulaire. Terminated at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-01.
Sponsored by TBF Genie Tissulaire · Phase 2, Interventional, and Treatment
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.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's enrollment of 12 is below the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →TBF Genie Tissulaire is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Disk of amniotic membrane apposed or buried on recurrent macular hole by the Investigator after vitrectomy and fluid-gas exchange.
Biological: Visio-AMTRIX
Chemically-treated, viro-inactivated, freeze-dried and irradiated amniotic membrane placed by the investigator during macular hole surgery
Closure of recurrent macular hole
Macular hole closure evaluated by optical coherence tomography (OCT)
Time frame: 6 months
Absence of adverse reaction
Analysis of all adverse events and comparison with adverse events observed after vitrectomy
Time frame: 7 days, 15 days, 1 month, 3 months, 6 months
Functional restoration after closure of the macular hole
Best corrected visual acuity (BCVA) and microperimetry assessment
Time frame: 7 days, 15 days, 1 month, 3 months, 6 months
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
Time frame: 1 month, 3 months, 6 months
Evaluation of the surgical technique of placing the membrane
Duration of coverage by Visio-AMTRIX and persistent after gas removal
Time frame: 7 days, 15 days, 1 month, 3 months, 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2020 to primary completion in Oct 2022, 28 months.
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This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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TBF Genie Tissulaire