Research Into Diagnostic and Prognostic Molecular and Imaging Biomarkers of Ocular Disorders Associated With Neurovascular Deregulation: Biocor Cohort

Ocular Rosacea Clinical Trial

— BIOCOR  

Official title:

Recherche de Biomarqueurs moléculaires et d'Imagerie Diagnostiques et Pronostiques Des Atteintes Oculaires associées à Des dérégulations Neurovasculaires : Cohorte Biocor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06466018
• Other study ID #: 2022-A02713-40
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2024
• Est. completion date: October 1, 2026

Study information

• Verified date: June 2024
• Source: Clinact
• Contact: CRA
• Phone: + 3315 841 28 98
• Email: contact[@]multihealthgroup.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Ocular Rosacea
• Pachychoroid Disease
• Rosacea

Intervention

Diagnostic Test:
• Schirmer test paper
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.

Locations

Country	Name	City	State
France	Departement of Ophthalmology, COCHIN Hospital	Paris Cedex 14

Sponsors (2)

Lead Sponsor	Collaborator
Clinact	Association CRO - Tous unis pour la vision

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Screening visit, visits A1, A2, and end-of-study visit
Primary	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	From inclusion to end of study (Inclusion, year 1, year 2, year 3)
Secondary	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 ;	From inclusion to end of study (Inclusion, year 1, year 2, year 3)
Secondary	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	At inclusion and end of study (Inclusion, year 3)