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

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Completed
• CT.gov ID: NCT01795001
• Collaborator: Fund for Scientific Research, Flanders, Belgium (Other), Funds for Research in Ophthalmology, Belgium (Other), Mieke Perdaens fund for Eye Research (Other)
• Enrollment: 460
• Location: 1
• Duration (Months): 59.4
• Patients Per Site Per Month: 7.7

Study Details

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	Phase
Fuchs' Endothelial Dystrophy	Other: No intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 460 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Molecular Pathogenesis of Late-onset Fuchs' Endothelial Corneal Dystrophy
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Sep 13, 2017
• Actual Study Completion Date: Sep 13, 2017

Arms and Interventions

Arm	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 [at time of prelevation (once, no intervention)]

   dosage of cytokine levels in aqueous humour (exploratory, non-interventional study)

2. gene expression levels [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 [at time of prelevation (once, no intervention)]

   immunohistochemistry and immunofluorescence

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Translational Cell and Tissue Research - campus Sint-Raf - UZ Leuven	Leuven		Belgium	3000

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT01795001
• Other Study ID Numbers: S55133
• First Posted: Feb 20, 2013
• Last Update Posted: May 24, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Universitaire Ziekenhuizen Leuven: pathophysiology
• Additional relevant MeSH terms: Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy

Study Results

No Results Posted as of May 24, 2018