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

Penetrating Keratoplasty Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00463723
• Other study ID #: FR-2000-2003
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: April 18, 2007
• Last updated: April 18, 2007

Study information

• Verified date: August 1999
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Penetrating Keratoplasty

Intervention

Drug:
• FK506 0.06% (eye drops)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Freiburg	Sucampo Pharmaceuticals, Inc.

References & Publications (1)

Reinhard T, Mayweg S, Reis A, Sundmacher R. Topical FK506 as immunoprophylaxis after allogeneic penetrating normal-risk keratoplasty: a randomized clinical pilot study. Transpl Int. 2005 Feb;18(2):193-7. — View Citation