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A Prospective Randomized Trial on Mycophenolate Mofetil in Risk Penetrating Keratoplasty

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00411515
First received: December 12, 2006
Last updated: December 14, 2006
Last verified: December 2006
History of Changes
  Purpose

The purpose of this prospectively randomized multicentre study was to prove the efficacy and safety of mycophenolate mofetil (MMF) to preventing graft rejection and improvement of clear graft survival following high-risk keratoplasty.

The patients of the MMF group receive MMF orally 2x1 g daily for 6 months. Endpoints were immune reaction free and clear graft survival and the occurence of side-effects.


Condition Intervention Phase
Corneal Transplantation
 Drug: Mycophenolate Mofetil 2x 1g
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Freiburg:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Keratoplasty with increased risk for immunologic graft rejection in the abscence of other risk factors for graft failure. (repeat keratoplasty, steroid-response, limbo-keratoplasty, oversized graft.

Exclusion Criteria:

  • Normal risk cases. Herpes-Keratitis. Glaucoma. Limbus stem cell deficiency.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411515

Locations
Germany
University Eye hospital
Freiburg, Germany, 79106
Sponsors and Collaborators
University Hospital Freiburg
Hoffmann-La Roche
Investigators
Study Chair: Thomas Reinhard, Prof. MD University eye hospital Freiburg
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00411515     History of Changes
Other Study ID Numbers: FR-2000-05-2006-06
Study First Received: December 12, 2006
Last Updated: December 14, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013