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
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.
- 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
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- 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