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

NCT01694914 | Completed Phase 3

• 2 other identifiers: 09080182010-A00234-35
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 4

Brief 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 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

Keywords

Corneal Transplantation; corneal organ culture medium; free animal compound medium

Outcome Measures

Primary Outcomes (1)

• the primary outcome is the endothelial cell density (ECD) of the corneal grafts.

  one year after graft

Study Arms (2)

Animal Compound Free Medium

EXPERIMENTAL

Patients in this arm receive a corneal graft stored in organ culture in a animal compound free medium

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

Procedure: corneal graft

Interventions

corneal graft PROCEDURE

Animal Compound Free Medium; organ culture medium containing 2% of fœtal calf serum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient is unlikely to comply with the requirements of the protocol

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Ministry of Health, France: collaborator

Study Sites (4)

CHU Besançon

Besançon, 25000, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Interventions

Corneal Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Gilles Thuret, MD-PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: September 27, 2012
• Study Start: January 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 30, 2015

Record last verified: 2015-01

Locations

FR (4)