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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Universitaire Ziekenhuizen Leuven
Sponsor:
Collaborators:
Fund for Scientific Research, Flanders, Belgium
Funds for Research in Ophthalmology, Belgium
Mieke Perdaens fund for Eye Research
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01795001
First received: January 30, 2013
Last updated: May 30, 2016
Last verified: December 2015
  Purpose
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 Intervention
Fuchs' Endothelial Dystrophy
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Molecular Pathogenesis of Late-onset Fuchs' Endothelial Corneal Dystrophy

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • cytokine levels [ Time Frame: at time of prelevation (once, no intervention) ] [ Designated as safety issue: No ]
    dosage of cytokine levels in aqueous humour (exploratory, non-interventional study)

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

  • protein content [ Time Frame: at time of prelevation (once, no intervention) ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 330
Study Start Date: October 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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.
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01795001

Locations
Belgium
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
Investigators
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 
Study First Received: January 30, 2013
Last Updated: May 30, 2016
Health Authority: Belgium: Ethics Committee
Individual Participant Data  
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:
pathophysiology

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

ClinicalTrials.gov processed this record on August 30, 2016