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A Prospective Randomized Trial on Mycophenolate Mofetil in Risk Penetrating Keratoplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00411515
First Posted: December 14, 2006
Last Update Posted: December 15, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hoffmann-La Roche
Information provided by:
University Hospital Freiburg
  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
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:

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: December 12, 2006
First Posted: December 14, 2006
Last Update Posted: December 15, 2006
Last Verified: December 2006

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action