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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Penetrating Keratoplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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FK506 0.06% (eye drops)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Thomas Reinhard, MD

Role: STUDY_CHAIR

University eye hospital Freiburg, Germany

References

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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.

Reference Type RESULT

PMID: 15691272 (View on PubMed)

Other Identifiers

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FR-2000-2003

Identifier Type: -

Identifier Source: org_study_id