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NCT Number: NCT06466018

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

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.

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Key information

Conditions

Ocular Rosacea Pachychoroid Disease Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departement of Ophthalmology, COCHIN Hospital

Paris, 75679, France

Location status: Recruiting

Location contact

Francine BEHAR-COHEN, Prof

CONTACT

Jean-Louis BOURGES, Prof

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Schirmer test paper

Diagnostic 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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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)

    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 ;

  2. Heart rate

    Time frame: At inclusion and end of study (Inclusion, year 3)

    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

CRA

CONTACT

[email protected]

+ 3315 841 28 98

Sponsors and collaborators

Lead sponsor

Clinact

Other

Collaborators

  • Association CRO - Tous unis pour la vision

Registry information

Official study title

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

Acronym: BIOCOR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 20, 2024
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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