NCT06450470 Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
| NCT ID | NCT06450470 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | TBF Genie Tissulaire |
| Condition | Progressive Keratoconus |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2024-11-25 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 116 participants in total. It began in 2024-11-25 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Patient subject to a legal protection measure or unable to express their consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06450470 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Progressive Keratoconus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06450470 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 116 participants.
Is NCT06450470 currently recruiting?
Yes, NCT06450470 is actively recruiting participants. Contact the research team at laurence.barnouin@tbf-lab.com for enrollment information.
Where is the NCT06450470 trial being conducted?
This trial is being conducted at Brest, France, Lyon, France, Marseille, France, Montpellier, France and 5 additional locations.
Who is sponsoring the NCT06450470 clinical trial?
NCT06450470 is sponsored by TBF Genie Tissulaire. The trial plans to enroll 116 participants.