Topical FK506 (Tacrolimus) for Prevention of Immune React... | NCT00463723

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

NCT00463723

Sponsor

University Hospital Freiburg

Status

Terminated

Last Update Posted

Apr 20, 2007Estimated

Enrollment

Not provided

Phase

Phase 2Phase 3

Conditions

Penetrating Keratoplasty

Interventions

FK506 0.06% (eye drops)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 1999

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 18, 2007

First Submission Date that Met QC Criteria

Apr 18, 2007

First Posted Date

Apr 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2007

Last Update Posted Date

Apr 20, 2007Estimated

Name	Class
Sucampo Pharmaceuticals, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
FK506 0.06% (eye drops)	Drug

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Thomas Reinhard, MD	University eye hospital Freiburg, Germany	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15691272	Result	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.

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D019999	Pharmaceutical Solutions

ID	Term
D016559	Tacrolimus
D009883	Ophthalmic Solutions