Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole

• Sponsor: TBF Genie Tissulaire (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05191628
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 29.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Holes; Retinal Detachment	Biological: Visio-AMTRIX	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole
• Actual Study Start Date: Jun 10, 2020
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Visio-AMTRIX 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

Outcome Measures

Primary Outcome Measures

1. Closure of recurrent macular hole [6 months]

   Macular hole closure evaluated by optical coherence tomography (OCT)

Secondary Outcome Measures

1. Absence of adverse reaction [7 days, 15 days, 1 month, 3 months, 6 months]

   Analysis of all adverse events and comparison with adverse events observed after vitrectomy

2. Functional restoration after closure of the macular hole [7 days, 15 days, 1 month, 3 months, 6 months]

   Best corrected visual acuity (BCVA) and microperimetry assessment

3. Anatomical restoration [1 month, 3 months, 6 months]

   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

4. Evaluation of the surgical technique of placing the membrane [7 days, 15 days, 1 month, 3 months, 6 months]

   Duration of coverage by Visio-AMTRIX and persistent after gas removal

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital de la Croix-Rousse, Hospices Civils de Lyon	Lyon		France	69004

Sponsors and Collaborators

• TBF Genie Tissulaire

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TBF Genie Tissulaire
• ClinicalTrials.gov Identifier: NCT05191628
• Other Study ID Numbers: Visio-AMTRIX-TMA-TBF; 2019-A01374-53
• First Posted: Jan 13, 2022
• Last Update Posted: Jan 13, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Retinal Detachment; Retinal Perforations

Study Results

No Results Posted as of Jan 13, 2022