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

May 22, 2018 updated by: Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

460

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Department of Translational Cell and Tissue Research - campus Sint-Raf - UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cytokine levels
Time Frame: at time of prelevation (once, no intervention)
dosage of cytokine levels in aqueous humour (exploratory, non-interventional study)
at time of prelevation (once, no intervention)
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)
at time of prelevation (once, no intervention)
protein content
Time Frame: at time of prelevation (once, no intervention)
immunohistochemistry and immunofluorescence
at time of prelevation (once, no intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

September 13, 2017

Study Completion (ACTUAL)

September 13, 2017

Study Registration Dates

First Submitted

January 30, 2013

First Submitted That Met QC Criteria

February 15, 2013

First Posted (ESTIMATE)

February 20, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2018

Last Update Submitted That Met QC Criteria

May 22, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S55133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

MEA and RT-qPCR data have been deposited in NCBI's Gene Expression Omnibus and are accessible through the Gene Expression Omnibus Series accession number GSE75676.

IPD Sharing Time Frame

Data already available.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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