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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00463723
Recruitment Status : Terminated
First Posted : April 20, 2007
Last Update Posted : April 20, 2007
Sponsor:
Collaborator:
Sucampo Pharmaceuticals, Inc.
Information provided by:
University Hospital Freiburg

Brief Summary:
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 or disease Intervention/treatment Phase
Penetrating Keratoplasty Drug: FK506 0.06% (eye drops) Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources





Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463723


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

Publications:
ClinicalTrials.gov Identifier: NCT00463723     History of Changes
Other Study ID Numbers: FR-2000-2003
First Posted: April 20, 2007    Key Record Dates
Last Update Posted: April 20, 2007
Last Verified: August 1999

Keywords provided by University Hospital Freiburg:
penetrating keratoplasty
graft rejection
immunosuppression

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action