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

Fuchs' Endothelial Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01795001
• Other study ID #: S55133
• Status: Completed
• Start date: October 2012
• Est. completion date: September 13, 2017

Study information

• Verified date: May 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: September 13, 2017
• Est. primary completion date: September 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fuchs' Endothelial Dystrophy
• Iridocorneal Endothelial Syndrome

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
Belgium	Department of Translational Cell and Tissue Research - campus Sint-Raf - UZ Leuven	Leuven

Sponsors (4)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Fund for Scientific Research, Flanders, Belgium, Funds for Research in Ophthalmology, Belgium, Mieke Perdaens fund for Eye Research

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cytokine levels	dosage of cytokine levels in aqueous humour (exploratory, non-interventional study)	at time of prelevation (once, no intervention)
Primary	gene expression levels	microarray expression analysis, reverse transcriptase - quantitative polymerase chain reaction (RT-qPCR), RNA-sequencing (exploratory, non-interventional study)	at time of prelevation (once, no intervention)
Primary	protein content	immunohistochemistry and immunofluorescence	at time of prelevation (once, no intervention)