Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus

NCT06450470 | Recruiting Phase 3

• 2 other identifiers: GMALC2024-A00004-43
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 9

Brief Summary

Crosslinking is a therapeutic technique used to increase the rigidity of the cornea in order to slow or stop progression of keratoconus. The main complication of the treatment of keratoconus by crosslinking is postoperative pain due to the removal of the corneal epithelium. Currently, the management of pain is done through the administration of artificial tears and paracetamol. The amniotic membrane is a biological tissue used in ophthalmology to treat injuries of the surface of the eye. It has healing and analgesic properties. The objective of this multicenter randomized study is to evaluate the benefit of placing an amniotic membrane on the eye post-crosslinking to reduce pain and promote corneal healing.

Conditions

Progressive Keratoconus

Outcome Measures

Primary Outcomes (2)

• Difference between the level of ocular pain experienced by patients treated with therapeutic lens + amniotic membrane (experimental) and by patients treated with therapeutic lens alone (active comparator)

  Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS)

  Day 0 bedtime, Day 1 wake-up, Day 1 bedtime, Day 2 wake-up, Day 2 consultation

• Difference in analgesic consumption between patients treated with a therapeutic lens + amniotic membrane (experimental) and patients treated with a therapeutic lens alone (active comparator)

  Amount in grams of analgesic consumed per day

  Day 0, Day 1, Day 2

Secondary Outcomes (5)

• Difference in visual acuity between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)

  Week 6

• Difference in corneal cicatrisation between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)

  Day 2, (Day 7), Week 6

• Difference in corneal thickness between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)

  Week 6

• Difference in topographic parameters (Kmax, inferior-superior) between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)

  Week 6

• Difference in dryness between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)

  Week 6

Study Arms (2)

Therapeutic lens alone

ACTIVE COMPARATOR

Device: Therapeutic lens alone

Therapeutic lens + amniotic membrane (Visio-AMTRIX)

EXPERIMENTAL

Combination Product: Therapeutic lens + amniotic membrane (Visio-AMTRIX)

Interventions

Therapeutic lens alone DEVICE

Therapeutic lens will be apposed on the patient's eye after crosslinking. Therapeutic lens will be maintained without interruption until the first postoperative visit (Day 2) when it will be removed by the investigator.

Therapeutic lens alone

Therapeutic lens + amniotic membrane (Visio-AMTRIX) COMBINATION_PRODUCT

Amniotic membrane (Visio-AMTRIX) will be apposed under therapeutic lens on the patient's eye after crosslinking. Amniotic membrane and therapeutic lens will be maintained without interruption until the first postoperative visit (Day 2) when it will be removed by the investigator.

Therapeutic lens + amniotic membrane (Visio-AMTRIX)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman between 18 and 65 years old.
• Indication for accelerated conventional crosslinking.
• Patient with progressive keratoconus (increase in Kmax of ≥ 0.5 diopters in 3 to 6 months or ≥ 1 diopter in 3 to 12 months with loss of 10 microns on minimum pachymetry in 3 to 12 month).
• Patient suffering from keratoconus with a compatible topographic form (Kmax ≥ 47.0 diopters (D) and difference inferior-superior of 1.5 D).
• Patient with a minimum corneal thickness greater than 400 microns.
• Informed and consenting patient.
• Patient physically and mentally capable of completing the post-operative pain assessment self-questionnaire.
• Patient having signed the informed consent of the French Ophthalmology Society for crosslinking.
• Patient affiliated to a social security system or beneficiary of such a system.

You may not qualify if:

• Woman without effective means of contraception, pregnant or breastfeeding.
• Patient who has already benefited from a crosslinking procedure on one of the eyes.
• Patient with a history of refractive surgery on one of the eyes.
• Patient with an intracorneal ring segment on one of the eyes.
• Patient suffering from a serious systemic pathology (autoimmune and/or immunodepressive)
• Patient with a psychiatric pathology.
• Patient on long-term analgesics and/or corticosteroids.
• Indication of crosslinking outside the classic protocol.
• Patient with central corneal opacity.
• Patient suffering from a severe dry eye syndrome or a neurotrophic keratitis.
• Patient with a history of ocular herpes.
• Patient with a history of ocular varicella-zoster virus infection.
• Patient with glaucoma.
• Patient treated with topical cyclosporine in the last 6 months.
• Patient deprived of liberty by a judicial or administrative decision.

Sponsors & Collaborators

• TBF Genie Tissulaire: lead

Study Sites (9)

CHU de Brest

Brest, 29609, France

RECRUITING

Hospices Civils de Lyon

Lyon, 69003, France

RECRUITING

Assistance Publique - Hôpitaux de Marseille

Marseille, 13005, France

RECRUITING

CHU de Montpellier

Montpellier, 34295, France

RECRUITING

CHU de Nantes

Nantes, 44000, France

NOT YET RECRUITING

Hôpital National de la Vision des Quinze-Vingts

Paris, 75012, France

RECRUITING

CHU de Saint-Etienne

Saint-Priest-en-Jarez, 42270, France

RECRUITING

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

RECRUITING

CHU de Toulouse

Toulouse, 31300, France

RECRUITING

Central Study Contacts

Laurence BARNOUIN, MD

CONTACT

0472686909; laurence.barnouin@tbf-lab.com

Justine BOSC, MSc

CONTACT

4 72 68 69 11; justine.bosc@tbf-lab.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: November 25, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)