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A Prospective Randomized Trial on Mycophenolate Mofetil in Risk Penetrating Keratoplasty

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00411515
Enrollment
Unknown
Registered
2006-12-14
Start date
Unknown
Completion date
Unknown
Last updated
2006-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Transplantation

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.

Interventions

DRUGMycophenolate Mofetil 2x 1g

Sponsors

Hoffmann-La Roche
CollaboratorINDUSTRY
University Hospital Freiburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026