Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01694914
First received: September 25, 2012
Last updated: November 6, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Corneal Transplantation
Procedure: corneal graft
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • the primary outcome is the endothelial cell density (ECD) of the corneal grafts. [ Time Frame: one year after graft ] [ Designated as safety issue: No ]

Estimated Enrollment: 122
Study Start Date: January 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Animal Compound Free Medium
Patients in this arm receive a corneal graft stored in organ culture in a animal compound free medium
Procedure: corneal graft
Active Comparator: organ culture medium containing 2% of fœtal calf serum
Patients in this arm receive a corneal graft stored in organ culture in a commercial organ culture medium containing 2% of fœtal calf serum
Procedure: corneal graft

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient is unlikely to comply with the requirements of the protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694914

Contacts
Contact: Gilles Thuret, MD-PhD (0)477120570 ext +33 gilles.thuret@univ-st-etienne.fr
Contact: Carine Labruyere, CRA (0)477120469 ext +33 carine.labruyere@chu-st-etienne.fr

Locations
France
CHU Besançon Not yet recruiting
Besancon, France, 25000
Principal Investigator: Bernard Delbosc, MD-PhD         
CHU Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Principal Investigator: Frédéric Chiambaretta, MD-PhD         
CHU Grenoble Not yet recruiting
Grenoble, France, 38043
Principal Investigator: Jean-Paul Romanet, MD-PhD         
CHU Saint-Etienne Recruiting
Saint-Etienne, France, 42055
Principal Investigator: Gilles Thuret, MD-PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Principal Investigator: Gilles Thuret, MD-PhD CHU Saint-Etienne
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01694914     History of Changes
Other Study ID Numbers: 0908018, 2010-A00234-35
Study First Received: September 25, 2012
Last Updated: November 6, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Corneal Transplantation
corneal organ culture medium
free animal compound medium

ClinicalTrials.gov processed this record on July 22, 2014