Trial record 2 of 20 for:    "Fuchs endothelial dystrophy" OR "Corneal Granular Dystrophies" OR "Hereditary Corneal Dystrophies" OR "Corneal Macular Dystrophy"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 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: January 7, 2014
Last verified: January 2013
  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
Fuchs' Endothelial Dystrophy

Study Type: Observational
Study Design: Observational Model: Case Control
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 and RT-qPCR (exploratory, non-interventional study)


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 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
FECD
normal control
non-FECD oedematous control

  Eligibility

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 oedematous corneas; in university hospital setting.

Criteria

Inclusion Criteria:

  • FECD

Exclusion Criteria:

  • ocular infection or other ocular disease (other than FECD)
  • ocular surgery in the past 3 weeks
  • prior ocular irradiation therapy
  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

No publications provided

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: January 7, 2014
Health Authority: Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on August 28, 2014