Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 12, 2006
December 14, 2006
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00411515 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Prospective Randomized Trial on Mycophenolate Mofetil in Risk Penetrating Keratoplasty
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Corneal Transplantation
Drug: Mycophenolate Mofetil 2x 1g
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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.
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00411515
FR-2000-05-2006-06
Not Provided
Not Provided
University Hospital Freiburg
Hoffmann-La Roche
Study Chair: Thomas Reinhard, Prof. MD University Eye Hospital, Freiburg
University Hospital Freiburg
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP