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

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.

Study Overview

• Status: Recruiting
• Conditions: Ocular Rosacea; Pachychoroid Disease
• Intervention / Treatment: Diagnostic test: Schirmer test paper

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: CRA; Phone Number: + 3315 841 28 98; Email: contact@multihealthgroup.com

Study Locations

• France
  • Paris Cedex 14, France, 75679
    • Recruiting
    • Departement of Ophthalmology, COCHIN Hospital
    • Contact: Jean-Louis BOURGES, Prof
    • Contact: Francine BEHAR-COHEN, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group	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.
Experimental: Ocular rosacea group	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.
Experimental: Pachychoroid group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Clinact
• Collaborators: Association CRO - Tous unis pour la vision

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: 2022-A02713-40

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No