Progressive KeratoconusPhase 3NCT06450470
Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
A Phase 3 study testing Therapeutic lens alone and Therapeutic lens + amniotic membrane (Visio-AMTRIX) in people with Progressive Keratoconus, run by TBF Genie Tissulaire at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Progressive Keratoconus
- What is being tested?
- Therapeutic lens alone and Therapeutic lens + amniotic membrane (Visio-AMTRIX)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 9 sitesFrance
- Study dates
- 25 Nov 2024to Nov 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
CHU de Brest
Brest, 29609
Béatrice COCHENER-LAMARD, Professor
- Recruiting
Hospices Civils de Lyon
Lyon, 69003
Carole BURILLON, Professor
- Recruiting
Assistance Publique - Hôpitaux de Marseille
Marseille, 13005
Thierry DAVID, Professor
- Recruiting
CHU de Montpellier
Montpellier, 34295
Vincent DAIEN, Professor
- Not yet recruiting
CHU de Nantes
Nantes, 44000
Isabelle ORIGNAC, MD
- Recruiting
Hôpital National de la Vision des Quinze-Vingts
Paris, 75012
Juliette KNOERI, MD
Vincent BORDERIE, Professor
- Recruiting
CHU de Saint-Etienne
Saint-Priest-en-Jarez, 42270
Marie-Caroline TRONE, MD
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Tristan BOURCIER, Professor
- Recruiting
CHU de Toulouse
Toulouse, 31300
Pierre FOURNIÉ, Professor
About this study
Official title: Multicenter, Randomized Study Evaluating the Use of a Non-sutured Sterile Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
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
- Being tested
- Therapeutic lens alone, Therapeutic lens + amniotic membrane (Visio-AMTRIX)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic lens aloneDevice
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 + 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.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic lens alone | Active comparator | Not described Receives: Device: Therapeutic lens alone |
| Therapeutic lens + amniotic membrane (Visio-AMTRIX) | Experimental | Not described Receives: Combination Product: Therapeutic lens + amniotic membrane (Visio-AMTRIX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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)
Determination of logMAR values of best corrected visual acuity
Measured: Week 6
Difference in corneal cicatrisation between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)
Healing evaluated under slit lamp by fluorescein examination
Measured: 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)
Corneal thickness evaluated by anterior segment optical coherence tomography.
Measured: 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)
Topographic parameters (Kmax, inferior-superior) evaluated by corneal topography
Measured: Week 6
Difference in dryness between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)
Dry eye and effect on vision evaluated between 0 (no disability) and 100 (greater disability) using Ocular Surface Disease Index (OSDI)
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start25 Nov 2024
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TBF Genie Tissulaire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450470
- Sponsor's protocol ID
- GMALC
- Other IDs
- 2024-A00004-43
- Status last verified
- Apr 2025
- First submitted
- 4 Jun 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized Study Evaluating the Use of a Non-sutured Sterile Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
- ClinicalTrials.gov ID
- NCT06450470
- Acronym / sponsor ID
- GMALC
- Conditions
- Progressive Keratoconus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- TBF Genie TissulaireIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic lens alone | Active comparator | Device: Therapeutic lens alone |
| Therapeutic lens + amniotic membrane (Visio-AMTRIX) | Experimental | Combination Product: Therapeutic lens + amniotic membrane (Visio-AMTRIX) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic lens aloneTherapeutic 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. | Device | Therapeutic lens alone |
| Therapeutic lens + amniotic membrane (Visio-AMTRIX)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. | Combination product | Therapeutic lens + amniotic membrane (Visio-AMTRIX) |
Primary outcome
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)
Time frame: Day 0 bedtime, Day 1 wake-up, Day 1 bedtime, Day 2 wake-up, Day 2 consultation
Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS)
Difference in analgesic consumption between patients treated with a therapeutic lens + amniotic membrane (experimental) and patients treated with a therapeutic lens alone (active comparator)
Time frame: Day 0, Day 1, Day 2
Amount in grams of analgesic consumed per day
5 secondary outcomes
Difference in visual acuity between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)
Time frame: Week 6
Difference in corneal cicatrisation between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)
Time frame: 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)
Time frame: 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)
Time frame: Week 6
Difference in dryness between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)
Time frame: Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Progressive Keratoconus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Therapeutic lens alone and Therapeutic lens + amniotic membrane (Visio-AMTRIX) in people with Progressive Keratoconus, run by TBF Genie Tissulaire at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurence BARNOUIN, MD (0472686909 ext. +33, laurence.barnouin@tbf-lab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Day 0 bedtime, Day 1 wake-up, Day 1 bedtime, Day 2 wake-up, Day 2 consultation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.