NCT00411515

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2006

Completed
Last Updated

December 15, 2006

Status Verified

December 1, 2006

First QC Date

December 12, 2006

Last Update Submit

December 14, 2006

Conditions

Corneal Transplantation

Interventions

Mycophenolate Mofetil 2x 1gDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Normal risk cases. Herpes-Keratitis. Glaucoma. Limbus stem cell deficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye hospital

Freiburg im Breisgau, 79106, Germany

Location

Related Publications (2)

  • 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. doi: 10.1111/j.1432-2277.2005.00126.x.

    PMID: 15910297RESULT

  • Birnbaum F, Mayweg S, Reis A, Bohringer D, Seitz B, Engelmann K, Messmer EM, Reinhard T. Mycophenolate mofetil (MMF) following penetrating high-risk keratoplasty: long-term results of a prospective, randomised, multicentre study. Eye (Lond). 2009 Nov;23(11):2063-70. doi: 10.1038/eye.2008.402. Epub 2009 Jan 16.

    PMID: 19151659DERIVED

Study Officials

  • Thomas Reinhard, Prof. MD

    University Eye Hospital, Freiburg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 12, 2006

First Posted

December 14, 2006

Last Updated

December 15, 2006

Record last verified: 2006-12

Locations

DE(1)