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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Freiburg
• Collaborator: Sucampo Pharmaceuticals, Inc.
• Treatments: Ophthalmic Solutions; Tacrolimus

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