A Prospective Randomized Trial on Mycophenolate Mofetil in Risk Penetrating Keratoplasty

This study has been completed.

First Received: December 12, 2006 Last Updated: December 14, 2006 History of Changes

Sponsors and Collaborators:	University Hospital Freiburg Hoffmann-La Roche
Information provided by:	University Hospital Freiburg
ClinicalTrials.gov Identifier:	NCT00411515

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 IV

Drug Information available for: Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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:

Reinhard T, Mayweg S, Sokolovska Y, Seitz B, Mittelviefhaus H, Engelmann K, Voiculescu A, Godehardt E, Sundmacher R. Systemic mycophenolate mofetil avoids immune reactions in penetrating high-risk keratoplasty: preliminary results of an ongoing prospectively randomized multicentre study. Transpl Int. 2005 Jun;18(6):703-8.

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

Study placed in the following topic categories:

Anti-Bacterial Agents
Immunologic Factors
Mycophenolic Acid
Mycophenolate mofetil
Immunosuppressive Agents

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Mycophenolic Acid

Mycophenolate mofetil
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009