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

This study has been terminated.
Sponsor:
Collaborator:
Sucampo Pharmaceuticals, Inc.
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00463723
First received: April 18, 2007
Last updated: NA
Last verified: August 1999
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention

Resource links provided by NLM:

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

Further study details as provided by University Hospital Freiburg:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463723

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

Publications:

ClinicalTrials.gov Identifier: NCT00463723     History of Changes
Other Study ID Numbers: FR-2000-2003
Study First Received: April 18, 2007
Last Updated: April 18, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013