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NCT00411515 Clinical Trial

A Prospective Randomized Trial on Mycophenolate Mofetil in Risk Penetrating Keratoplasty

Corneal Transplantation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00411515
Other study ID # FR-2000-05-2006-06
Secondary ID
Status Completed
Phase Phase 4
First received December 12, 2006
Last updated December 14, 2006

Study information
Verified date December 2006
Source University Hospital Freiburg
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Mycophenolate Mofetil 2x 1g

Locations
Country Name City State
Germany University Eye hospital Freiburg

Sponsors (2)
Lead Sponsor Collaborator
University Hospital Freiburg Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 prospectiv — View Citation

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