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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014