A Prospective Randomized Trial on Mycophenolate Mofetil in Risk Penetrating Keratoplasty

University Hospital Freiburg

Status and phase: Completed; Phase 4

Conditions: Corneal Transplantation

Treatments: Drug: Mycophenolate Mofetil 2x 1g

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00411515

FR-2000-05-2006-06

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)