Fuchs' Endothelial DystrophyNCT01795001
The Molecular Pathogenesis of Late-onset Fuchs' Endothelial Corneal Dystrophy
An observational study of Fuchs' Endothelial Dystrophy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fuchs' Endothelial Dystrophy
- How many people
- 460 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2012to 13 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Fuchs' Endothelial Corneal Dystrophy (FECD), normal control patients, and patients with non-Fuchs edematous corneas; in university hospital setting.
Who may be able to join
- FECD
- normal corneas (including enucleations for uveal melanoma)
- non-FECD oedematous corneas
Who cannot join
- prior irradiation therapy for uveal melanoma
- corneal extension of uveal melanoma
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of Translational Cell and Tissue Research - campus Sint-Raf - UZ Leuven
Leuven, 3000
About this study
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.
- Conditions
- Fuchs' Endothelial Dystrophy
- Being tested
- No intervention
- Keywords
- pathophysiology
- Medical subject headings
- Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| late-onset FECD | tissue samples from patients with late-onset Fuchs' endothelial corneal dystrophy (FECD) Receives: Other: No intervention | |
| normal control | tissue samples from patients with normal corneas Receives: Other: No intervention | |
| non-FECD edematous control | tissue samples from patients with corneal edema but without FECD Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokine levels
dosage of cytokine levels in aqueous humour (exploratory, non-interventional study)
Measured: at time of prelevation (once, no intervention)
gene expression levels
microarray expression analysis, reverse transcriptase - quantitative polymerase chain reaction (RT-qPCR), RNA-sequencing (exploratory, non-interventional study)
Measured: at time of prelevation (once, no intervention)
protein content
immunohistochemistry and immunofluorescence
Measured: at time of prelevation (once, no intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startOct 2012
- Primary completion13 Sep 2017
- Study completion13 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuchs' Endothelial DystrophyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, Funds for Research in Ophthalmology, Belgium, Mieke Perdaens fund for Eye Research
- Responsible party
- Sponsor
- Investigators
- Joost J van den Oord, MD, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795001
- Sponsor's protocol ID
- S55133
- Status last verified
- May 2018
- First submitted
- 30 Jan 2013
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Molecular Pathogenesis of Late-onset Fuchs' Endothelial Corneal Dystrophy
- ClinicalTrials.gov ID
- NCT01795001
- Acronym / sponsor ID
- S55133
- Conditions
- Fuchs' Endothelial Dystrophy
- Keywords
- pathophysiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, Funds for Research in Ophthalmology, Belgium, Mieke Perdaens fund for Eye Research
- Study start
- Oct 2012
- Primary completion
- 13 Sep 2017 (actual)
- Study completion
- 13 Sep 2017 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| late-onset FECD | – | Other: No interventiontissue samples from patients with late-onset Fuchs' endothelial corneal dystrophy (FECD) |
| normal control | – | Other: No interventiontissue samples from patients with normal corneas |
| non-FECD edematous control | – | Other: No interventiontissue samples from patients with corneal edema but without FECD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Fuchs' Endothelial Corneal Dystrophy (FECD), normal control patients, and patients with non-Fuchs edematous corneas; in university hospital setting.
Key inclusion criteria (3 listed)
- FECD
- normal corneas (including enucleations for uveal melanoma)
- non-FECD oedematous corneas
Key exclusion criteria (2 listed)
- prior irradiation therapy for uveal melanoma
- corneal extension of uveal melanoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | late-onset FECD, non-FECD edematous control, normal control |
Primary outcome
cytokine levels
Time frame: at time of prelevation (once, no intervention)
dosage of cytokine levels in aqueous humour (exploratory, non-interventional study)
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)
protein content
Time frame: at time of prelevation (once, no intervention)
immunohistochemistry and immunofluorescence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Fuchs' Endothelial Dystrophy
Active, not recruitingPhase 3
Descemet Endothelial Thickness Comparison Trial II
Fuchs, Fuchs Dystrophy
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
RecruitingPhase 2
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Fuchs
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joost J van den Oord, MD, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fuchs' Endothelial Dystrophy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cytokine levels (time frame: at time of prelevation (once, no intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.