NCT00463723

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.

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
Last Updated

April 20, 2007

Status Verified

August 1, 1999

First QC Date

April 18, 2007

Last Update Submit

April 18, 2007

Conditions

Penetrating Keratoplasty

Keywords

penetrating keratoplastygraft rejectionimmunosuppression

Interventions

FK506 0.06% (eye drops)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Penetrating keratoplasty for Keratoconus
  • Penetrating keratoplasty for Fuchs endothelial dystrophie
  • Penetrating keratoplasty for Bullous keratopathy

You may not qualify if:

  • Glaucoma
  • Limbal stem cell deficiency
  • Herpetic eye disease
  • Repeat Keratoplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1111/j.1432-2277.2004.00006.x.

    PMID: 15691272RESULT

MeSH Terms

Interventions

TacrolimusOphthalmic Solutions

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Thomas Reinhard, MD

    University eye hospital Freiburg, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 20, 2007

Last Updated

April 20, 2007

Record last verified: 1999-08