Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-06 @ 10:11 PM
Study NCT ID:
NCT06466018
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research Into Diagnostic and Prognostic Molecular and Imaging Biomarkers of Ocular Disorders Associated With Neurovascular Deregulation: Biocor Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-13', 'studyFirstSubmitDate': '2023-11-29', 'studyFirstSubmitQcDate': '2024-06-13', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical phenotype of ocular rosacea', 'timeFrame': 'Screening visit, visits A1, A2, and end-of-study visit', 'description': '* OSDI score\n* QoL score VF24 questionnaire\n* Stage and type of Rosacea\n* Blepharitis stage\n* Oxford score\n* Schirmer score\n* OSI Index\n* Meibomian meibography score\n* Quantification of corneal opacity and neovascularization by standardized score\n* Limbal insufficiency score\n* Clinical evolution under therapeutic effect'}, {'measure': 'Pachychoroid clinical phenotype', 'timeFrame': 'From inclusion to end of study (Inclusion, year 1, year 2, year 3)', 'description': '* Measurement of total choroidal thickness\n* Measurement of choroidal vascular caliber\n* Measurement of foveolar avascular area\n* Calculation of fundus autofluorescence areas\n* Calculation of retinal non-perfusion areas\n* Cone counting'}], 'secondaryOutcomes': [{'measure': 'Evolvolution of clinical profile of each phenotype in the cohort', 'timeFrame': 'From inclusion to end of study (Inclusion, year 1, year 2, year 3)', 'description': 'Progression of limbic insufficiency (Deng grades) of ocular rosacea;\n\n* Ocular dryness (Oxford score, OSDI questionnaire);\n* Quantification of corneal nerves (density),\n* tear film (OSI score, Schirmer score, BUT score, OXFORD score),\n* meibomian glands (meibographic score);\n* variation in the thickness of the subfoveal choroid, a vascular index of the choroid quantified on analysis of the foveolar section in EDI;\n* Quantification of the surface area of epithelial atrophy on blue autofluorescence blue ;'}, {'measure': 'Heart rate', 'timeFrame': 'At inclusion and end of study (Inclusion, year 3)', 'description': '* Measurement of static and dynamic heart rate variability (HRV) in patients and control group\n* Correlation of HRV with phenotypic stages and biological markers of interest'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ocular Rosacea', 'Pachychoroid Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female \\> 18 years of age, of European origin, with signed ± genetic consent\n* Clear ocular media for OCT and autofluorescence imaging\n* Signed consent form\n* Be affiliated to a health insurance scheme\n* Control patients are patients scheduled for cataract surgery or visual assessment.\n\nExclusion Criteria:\n\n* High myopia \\> 6D\n* Diabetic retinopathy, hereditary retinal dystrophy, untreated retinal detachment, choroidal ocular tumor, choroidal hemangioma\n* Epithelial or stromal keratopathy other than ocular rosacea\n* Corneal surgery less than 3 months old, keratoplasty\n* Deprived of liberty or under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT06466018', 'acronym': 'BIOCOR', 'briefTitle': 'Research Into Diagnostic and Prognostic Molecular and Imaging Biomarkers of Ocular Disorders Associated With Neurovascular Deregulation: Biocor Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Clinact'}, 'officialTitle': "Recherche de Biomarqueurs moléculaires et d'Imagerie Diagnostiques et Pronostiques Des Atteintes Oculaires associées à Des dérégulations Neurovasculaires : Cohorte Biocor", 'orgStudyIdInfo': {'id': '2022-A02713-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ocular rosacea group', 'interventionNames': ['Diagnostic Test: Schirmer test paper']}, {'type': 'EXPERIMENTAL', 'label': 'Pachychoroid group', 'interventionNames': ['Diagnostic Test: Schirmer test paper']}, {'type': 'OTHER', 'label': 'Control group', 'interventionNames': ['Diagnostic Test: Schirmer test paper']}], 'interventions': [{'name': 'Schirmer test paper', 'type': 'DIAGNOSTIC_TEST', 'description': '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.\n\nDuring 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.\n\nTears 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.', 'armGroupLabels': ['Control group', 'Ocular rosacea group', 'Pachychoroid group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75679', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Louis BOURGES, Prof', 'role': 'CONTACT'}, {'name': 'Francine BEHAR-COHEN, Prof', 'role': 'CONTACT'}], 'facility': 'Departement of Ophthalmology, COCHIN Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'CRA', 'role': 'CONTACT', 'email': 'contact@multihealthgroup.com', 'phone': '+ 3315 841 28 98'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinact', 'class': 'OTHER'}, 'collaborators': [{'name': 'Association CRO - Tous unis pour la vision', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}