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

NCT06466018 | Recruiting

• 1 other identifier: 2022-A02713-40
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ocular Rosacea; Pachychoroid Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Evolvolution of clinical profile of each phenotype in the cohort

  From inclusion to end of study (Inclusion, year 1, year 2, year 3)

• Heart rate

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

Study Arms (3)

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

Interventions

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.

Control group; Ocular rosacea group; Pachychoroid group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinact: lead
• Association CRO - Tous unis pour la vision: collaborator

Study Sites (1)

Departement of Ophthalmology, COCHIN Hospital

Paris, 75679, France

RECRUITING

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

CRA

CONTACT

+ 3315 841 28 98; contact@multihealthgroup.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: June 20, 2024
• Study Start: March 19, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

FR (1)