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Topical FK506 (Tacrolimus) for Prevention of Immune Reactions Following Penetrating Keratoplasty

This study has been terminated.
Sucampo Pharmaceuticals, Inc.
Information provided by:
University Hospital Freiburg Identifier:
First received: April 18, 2007
Last updated: NA
Last verified: August 1999
History: No changes posted
Background: Patients following allogeneic keratoplasty are treated with topical and frequently with systemic steroids to prevent immune reactions. Steroids are known to yield good results, but exert a wide range of side effects. The efficacy of topial FK506 in preventing immune reactions has already been demonstrated experimentally. FK506, an IL-2-inhibitor like Cyclosporin A (CSA), is known to be approximately 100 fold more potent than CSA. Aim of the study: In this study the efficacy and safety of topical FK506 will be compared to our standard treatment (i.e. steroids) after penetrating normal-risk keratoplasty.

Condition Intervention Phase
Penetrating Keratoplasty Drug: FK506 0.06% (eye drops) Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by University Hospital Freiburg:


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Penetrating keratoplasty for Keratoconus
  • Penetrating keratoplasty for Fuchs endothelial dystrophie
  • Penetrating keratoplasty for Bullous keratopathy

Exclusion Criteria:

  • Glaucoma
  • Limbal stem cell deficiency
  • Herpetic eye disease
  • Repeat Keratoplasty
  Contacts and Locations
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Please refer to this study by its identifier: NCT00463723

Sponsors and Collaborators
University Hospital Freiburg
Sucampo Pharmaceuticals, Inc.
Study Chair: Thomas Reinhard, MD University eye hospital Freiburg, Germany
  More Information

Publications: Identifier: NCT00463723     History of Changes
Other Study ID Numbers: FR-2000-2003
Study First Received: April 18, 2007
Last Updated: April 18, 2007

Keywords provided by University Hospital Freiburg:
penetrating keratoplasty
graft rejection

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017