A Prospective Randomized Trial on Mycophenolate Mofetil in Risk Penetrating Keratoplasty
Sponsor
University Hospital Freiburg (Other)
Overall Status
Completed
CT.gov ID
NCT00411515
Collaborator
Hoffmann-La Roche (Industry)
1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00411515
Other Study ID Numbers:
- FR-2000-05-2006-06
First Posted:
Dec 14, 2006
Last Update Posted:
Dec 15, 2006
Last Verified:
Dec 1, 2006
Additional relevant MeSH terms: