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The Molecular Pathogenesis of Late-onset Fuchs' Endothelial Corneal Dystrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01795001
Recruitment Status : Unknown
Verified December 2015 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : February 20, 2013
Last Update Posted : June 1, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to gain further insights into the molecular pathogenesis of Fuchs' endothelial corneal dystrophy (FECD), to identify targets for potential specific drug therapy.

Condition or disease Intervention/treatment
Fuchs' Endothelial Dystrophy Other: No intervention

Study Design

Study Type : Observational
Estimated Enrollment : 330 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Molecular Pathogenesis of Late-onset Fuchs' Endothelial Corneal Dystrophy
Study Start Date : October 2012
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Groups and Cohorts

Group/Cohort Intervention/treatment
late-onset FECD
tissue samples from patients with late-onset Fuchs' endothelial corneal dystrophy (FECD)
Other: No intervention
normal control
tissue samples from patients with normal corneas
Other: No intervention
non-FECD edematous control
tissue samples from patients with corneal edema but without FECD
Other: No intervention

Outcome Measures

Primary Outcome Measures :
  1. cytokine levels [ Time Frame: at time of prelevation (once, no intervention) ]
    dosage of cytokine levels in aqueous humour (exploratory, non-interventional study)

  2. gene expression levels [ Time Frame: at time of prelevation (once, no intervention) ]
    microarray expression analysis, reverse transcriptase - quantitative polymerase chain reaction (RT-qPCR), RNA-sequencing (exploratory, non-interventional study)

  3. protein content [ Time Frame: at time of prelevation (once, no intervention) ]
    immunohistochemistry and immunofluorescence

Biospecimen Retention:   Samples With DNA
Non-interventional study on corneal endothelium, anterior eye chamber fluid and paraffin-embedded corneal tissue, using molecular techniques to identify and characterise the molecular players involved in the pathogenesis of FECD.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Fuchs' Endothelial Corneal Dystrophy (FECD), normal control patients, and patients with non-Fuchs edematous corneas; in university hospital setting.

Inclusion Criteria:

  • FECD
  • normal corneas (including enucleations for uveal melanoma)
  • non-FECD oedematous corneas

Exclusion Criteria:

  • prior irradiation therapy for uveal melanoma
  • corneal extension of uveal melanoma
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795001

Department of Translational Cell and Tissue Research - campus Sint-Raf - UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: An-Katrien De Roo    +32 16 33 65 88      
Principal Investigator: Joost J van den Oord, prof. dr.         
Principal Investigator: Beatrijs Foets, prof. dr.         
Sub-Investigator: An-Katrien De Roo, dr.         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Fund for Scientific Research, Flanders, Belgium
Funds for Research in Ophthalmology, Belgium
Mieke Perdaens fund for Eye Research
Principal Investigator: Joost J van den Oord, MD, PhD KU Leuven
More Information

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01795001     History of Changes
Other Study ID Numbers: S55133
First Posted: February 20, 2013    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will make the microarray and RT-qPCR data publically available through NCBI's Gene Expression Omnibus (GEO), upon publication of our findings.

Keywords provided by Universitaire Ziekenhuizen Leuven:

Additional relevant MeSH terms:
Fuchs' Endothelial Dystrophy
Iridocorneal Endothelial Syndrome
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Iris Diseases
Uveal Diseases