Corneal TransplantationPhase 3NCT01694914
Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium
A Phase 3 study testing corneal graft in people with Corneal Transplantation, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
Trial summary
At present, all commercially available corneal organ culture media contain foetal calf serum (FCS) and sometimes other compounds extracted from animals. These compounds are necessary for corneal cell survival but are problematic because they theoretically have risk of anthropozoonosis transmission, especially for new… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Transplantation
- What is being tested?
- corneal graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 4 sitesFrance
- Study dates
- Jan 2012to Feb 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients
- over 18 years of age
- Clinically proven corneal disease
- Registered on the French National waiting list (GLAC)
- Patient informed consent
- Patient who needs a 8.25mm of diameter perforating keratoplasty, either isolated or combined with lens surgery
- Low immune rejection risk (< 2 quadrants of neovascularization, no previous history of herpetic keratitis nor graft rejection)
- No previous history of glaucoma or elevated intra ocular pressure (>22 mm
Who cannot join
- Patient is unlikely to comply with the requirements of the protocol
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Besançon
Besançon, 25000
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
CHU Grenoble
Grenoble, 38043
CHU Saint-Etienne
Saint-Etienne, 42055
About this study
At present, all commercially available corneal organ culture media contain foetal calf serum (FCS) and sometimes other compounds extracted from animals. These compounds are necessary for corneal cell survival but are problematic because they theoretically have risk of anthropozoonosis transmission, especially for new variant of CJD and the variability between FCS batches influence graft quality. Our laboratory research allowed in vitro and ex vivo validation of a new medium free compound animal. We proved its superiority over conventional medium containing 2% FCS for endothelial cell survival during the storage time. The goal of this clinical trial is now to assess its superiority in patients.
- Conditions
- Corneal Transplantation
- Being tested
- corneal graft
- Keywords
- Corneal Transplantation, corneal organ culture medium, free animal compound medium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corneal graftProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Animal Compound Free Medium | Experimental | Patients in this arm receive a corneal graft stored in organ culture in a animal compound free medium Receives: Procedure: corneal graft |
| organ culture medium containing 2% of fœtal calf serum | Active comparator | Patients in this arm receive a corneal graft stored in organ culture in a commercial organ culture medium containing 2% of fœtal calf serum Receives: Procedure: corneal graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
the primary outcome is the endothelial cell density (ECD) of the corneal grafts.
Measured: one year after graft
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal TransplantationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Gilles Thuret, MD-PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694914
- Sponsor's protocol ID
- 0908018
- Other IDs
- 2010-A00234-35
- Status last verified
- Jan 2015
- First submitted
- 25 Sep 2012
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium
- ClinicalTrials.gov ID
- NCT01694914
- Acronym / sponsor ID
- 0908018
- Conditions
- Corneal Transplantation
- Keywords
- Corneal Transplantation, corneal organ culture medium, free animal compound medium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jan 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Sep 2012 (estimated)
- 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.
At present, all commercially available corneal organ culture media contain foetal calf serum (FCS) and sometimes other compounds extracted from animals. These compounds are necessary for corneal cell survival but are problematic because they theoretically have risk of anthropozoonosis transmission, especially for new variant of CJD and the variability between FCS batches influence graft quality. Our laboratory research allowed in vitro and ex vivo validation of a new medium free compound animal. We proved its superiority over conventional medium containing 2% FCS for endothelial cell survival during the storage time. The goal of this clinical trial is now to assess its superiority in patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Animal Compound Free Medium | Experimental | Procedure: corneal graftPatients in this arm receive a corneal graft stored in organ culture in a animal compound free medium |
| organ culture medium containing 2% of fœtal calf serum | Active comparator | Procedure: corneal graftPatients in this arm receive a corneal graft stored in organ culture in a commercial organ culture medium containing 2% of fœtal calf serum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female patients
- over 18 years of age
- Clinically proven corneal disease
- Registered on the French National waiting list (GLAC)
- Patient informed consent
Key exclusion criteria (1 listed)
- Patient is unlikely to comply with the requirements of the protocol
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 |
|---|---|---|
| corneal graft | Procedure or surgery | Animal Compound Free Medium, organ culture medium containing 2% of fœtal calf serum |
Primary outcome
the primary outcome is the endothelial cell density (ECD) of the corneal grafts.
Time frame: one year after graft
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
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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. This study is not recruiting at the moment.
Gilles Thuret, MD-PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
4 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 corneal graft in people with Corneal Transplantation, run by Centre Hospitalier Universitaire de Saint Etienne at 4 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 8 inclusion and 1 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: finished, as of the sponsor's last update on 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the primary outcome is the endothelial cell density (ECD) of the corneal grafts. (time frame: one year after graft). 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 30 Jan 2015.