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A Prospective Randomized Trial on Mycophenolate Mofetil in Risk Penetrating Keratoplasty

This study has been completed.
Hoffmann-La Roche
Information provided by:
University Hospital Freiburg Identifier:
First received: December 12, 2006
Last updated: December 14, 2006
Last verified: December 2006

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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by University Hospital Freiburg:


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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.
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Please refer to this study by its identifier: NCT00411515

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

Publications automatically indexed to this study by Identifier (NCT Number): 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

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on August 21, 2017