Ocular RosaceaBIOCORNCT06466018
Research Into Diagnostic and Prognostic Molecular and Imaging Biomarkers of Ocular Disorders Associated With Neurovascular Deregulation: Biocor Cohort
A study testing Schirmer test paper in people with Ocular Rosacea and Pachychoroid Disease, run by Clinact at 1 site in France.
Trial summary
BIOCOR is an interventional clinical trial whose main objectives are Objectif are identify molecular biomarker(s) of ocular rosacea and pachychoroid. Endpoints are : Correlation between pachychoroidosis (defined by choroidal phenotype parameters in OCT and autofluorescence) or the stage of ocular rosacea (ROSCO(29)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular Rosacea, Pachychoroid Disease
- What is being tested?
- Schirmer test paper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2024to 1 Oct 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female > 18 years of age, of European origin, with signed ± genetic consent
- Clear ocular media for OCT and autofluorescence imaging
- Signed consent form
- Be affiliated to a health insurance scheme
- Control patients are patients scheduled for cataract surgery or visual assessment.
Who cannot join
- High myopia > 6D
- Diabetic retinopathy, hereditary retinal dystrophy, untreated retinal detachment, choroidal ocular tumor, choroidal hemangioma
- Epithelial or stromal keratopathy other than ocular rosacea
- Corneal surgery less than 3 months old, keratoplasty
- Deprived of liberty or under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Departement of Ophthalmology, COCHIN Hospital
Paris, 75679
Jean-Louis BOURGES, Prof
Francine BEHAR-COHEN, Prof
About this study
Official title: Recherche de Biomarqueurs moléculaires et d'Imagerie Diagnostiques et Pronostiques Des Atteintes Oculaires associées à Des dérégulations Neurovasculaires : Cohorte Biocor
BIOCOR is an interventional clinical trial whose main objectives are Objectif are identify molecular biomarker(s) of ocular rosacea and pachychoroid. Endpoints are : Correlation between pachychoroidosis (defined by choroidal phenotype parameters in OCT and autofluorescence) or the stage of ocular rosacea (ROSCO(29) definition) and biological markers selected on the basis of preclinical work (animal model) and by unbiased methods (proteomics, metabolomics, meibum lipidomics). The study of circulating, ocular and functional biomarkers would enable us to confirm our hypothesis and identify patients who could benefit from treatments that regulate the ANS and/or mineralocorticoid pathways.
- Conditions
- Ocular Rosacea, Pachychoroid Disease
- Being tested
- Schirmer test paper
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schirmer test paperDiagnostic test
This paper is centrifuged and your tears are collected then frozen before analysis. We collect the fat from your tears by scraping the edge of your lower eyelid with small sterile tweezers. All surgical waste will be collected during eye surgeries only if you must have them.
During each ocular surgical procedure, the vitreous, subretinal fluids and/or aqueous humor will eventually be recovered when required by the procedure. The rest of the blood samples, not used during diagnostic analyses, will be kept for later analyses.
Tears will be collected using a non-invasive and painless method that takes around ten minutes. The tissues (connectiva, cornea, retina, epi-retinal membrane) which must have been removed when required by the surgical procedure will also be preserved.
| Study group | Role | What they receive |
|---|---|---|
| Ocular rosacea group | Experimental | Not described Receives: Diagnostic Test: Schirmer test paper |
| Pachychoroid group | Experimental | Not described Receives: Diagnostic Test: Schirmer test paper |
| Control group | Other | Not described Receives: Diagnostic Test: Schirmer test paper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical phenotype of ocular rosacea
- OSDI score
- QoL score VF24 questionnaire
- Stage and type of Rosacea
- Blepharitis stage
- Oxford score
- Schirmer score
- OSI Index
- Meibomian meibography score
- Quantification of corneal opacity and neovascularization by standardized score
- Limbal insufficiency score
- Clinical evolution under therapeutic effect
Measured: Screening visit, visits A1, A2, and end-of-study visit
Pachychoroid clinical phenotype
- Measurement of total choroidal thickness
- Measurement of choroidal vascular caliber
- Measurement of foveolar avascular area
- Calculation of fundus autofluorescence areas
- Calculation of retinal non-perfusion areas
- Cone counting
Measured: From inclusion to end of study (Inclusion, year 1, year 2, year 3)
Secondary outcomes (2)
Evolvolution of clinical profile of each phenotype in the cohort
Progression of limbic insufficiency (Deng grades) of ocular rosacea;
- Ocular dryness (Oxford score, OSDI questionnaire);
- Quantification of corneal nerves (density),
- tear film (OSI score, Schirmer score, BUT score, OXFORD score),
- meibomian glands (meibographic score);
- variation in the thickness of the subfoveal choroid, a vascular index of the choroid quantified on analysis of the foveolar section in EDI;
- Quantification of the surface area of epithelial atrophy on blue autofluorescence blue ;
Measured: From inclusion to end of study (Inclusion, year 1, year 2, year 3)
Heart rate
- Measurement of static and dynamic heart rate variability (HRV) in patients and control group
- Correlation of HRV with phenotypic stages and biological markers of interest
Measured: At inclusion and end of study (Inclusion, year 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start19 Mar 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular RosaceaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinact
- Sponsor type
- University, hospital or other
- Collaborators
- Association CRO - Tous unis pour la vision
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466018
- Sponsor's protocol ID
- 2022-A02713-40
- Acronym
- BIOCOR
- Status last verified
- Jun 2024
- First submitted
- 29 Nov 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recherche de Biomarqueurs moléculaires et d'Imagerie Diagnostiques et Pronostiques Des Atteintes Oculaires associées à Des dérégulations Neurovasculaires : Cohorte Biocor
- ClinicalTrials.gov ID
- NCT06466018
- Acronym / sponsor ID
- BIOCOR / 2022-A02713-40
- Conditions
- Ocular Rosacea, Pachychoroid Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- ClinactUniversity, hospital or other
- Collaborators
- Association CRO - Tous unis pour la vision
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 20 Jun 2024 (actual)
- 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.
BIOCOR is an interventional clinical trial whose main objectives are Objectif are identify molecular biomarker(s) of ocular rosacea and pachychoroid. Endpoints are : Correlation between pachychoroidosis (defined by choroidal phenotype parameters in OCT and autofluorescence) or the stage of ocular rosacea (ROSCO(29) definition) and biological markers selected on the basis of preclinical work (animal model) and by unbiased methods (proteomics, metabolomics, meibum lipidomics). The study of circulating, ocular and functional biomarkers would enable us to confirm our hypothesis and identify patients who could benefit from treatments that regulate the ANS and/or mineralocorticoid pathways.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ocular rosacea group | Experimental | Diagnostic Test: Schirmer test paper |
| Pachychoroid group | Experimental | Diagnostic Test: Schirmer test paper |
| Control group | Other | Diagnostic Test: Schirmer test paper |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female > 18 years of age, of European origin, with signed ± genetic consent
- Clear ocular media for OCT and autofluorescence imaging
- Signed consent form
- Be affiliated to a health insurance scheme
- Control patients are patients scheduled for cataract surgery or visual assessment.
Key exclusion criteria (5 listed)
- High myopia > 6D
- Diabetic retinopathy, hereditary retinal dystrophy, untreated retinal detachment, choroidal ocular tumor, choroidal hemangioma
- Epithelial or stromal keratopathy other than ocular rosacea
- Corneal surgery less than 3 months old, keratoplasty
- Deprived of liberty or under guardianship or curatorship
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 |
|---|---|---|
| Schirmer test paperThis paper is centrifuged and your tears are collected then frozen before analysis. We collect the fat from your tears by scraping the edge of your lower eyelid with small sterile tweezers. All surgical waste will be collected during eye surgeries only if you must have them. During each ocular surgical procedure, the vitreous, subretinal fluids and/or aqueous humor will eventually be recovered when required by the procedure. The rest of the blood samples, not used during diagnostic analyses, will be kept for later analyses. Tears will be collected using a non-invasive and painless method that takes around ten minutes. The tissues (connectiva, cornea, retina, epi-retinal membrane) which must have been removed when required by the surgical procedure will also be preserved. | Diagnostic test | Control group, Ocular rosacea group, Pachychoroid group |
Primary outcome
Clinical phenotype of ocular rosacea
Time frame: Screening visit, visits A1, A2, and end-of-study visit
* OSDI score * QoL score VF24 questionnaire * Stage and type of Rosacea * Blepharitis stage * Oxford score * Schirmer score * OSI Index * Meibomian meibography score * Quantification of corneal opacity and neovascularization by standardized score * Limbal insufficiency score * Clinical evolution under therapeutic effect
Pachychoroid clinical phenotype
Time frame: From inclusion to end of study (Inclusion, year 1, year 2, year 3)
* Measurement of total choroidal thickness * Measurement of choroidal vascular caliber * Measurement of foveolar avascular area * Calculation of fundus autofluorescence areas * Calculation of retinal non-perfusion areas * Cone counting
2 secondary outcomes
Evolvolution of clinical profile of each phenotype in the cohort
Time frame: From inclusion to end of study (Inclusion, year 1, year 2, year 3)
Heart rate
Time frame: At inclusion and end of study (Inclusion, year 3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schirmer test paper in people with Ocular Rosacea and Pachychoroid Disease, run by Clinact at 1 site in France.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Jun 2024. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CRA (+ 3315 841 28 98, contact@multihealthgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical phenotype of ocular rosacea (time frame: Screening visit, visits A1, A2, and end-of-study visit). The study lists 2 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 20 Jun 2024.