Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-07 @ 1:26 AM
Study NCT ID:
NCT02891694
Status:
COMPLETED
Last Update Posted:
2020-12-10
First Post:
2016-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metalloproteinases and Recurrent Corneal Erosion Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2016-08-25', 'studyFirstSubmitQcDate': '2016-09-06', 'lastUpdatePostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'expression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) in epithelial cells', 'timeFrame': 'baseline'}]}, 'conditionsModule': {'conditions': ['Recurrent Corneal Erosion Syndrome']}, 'descriptionModule': {'briefSummary': 'Recurrent corneal erosion (RCE) syndrome can be observed either in the context of a dystrophy of the basement membrane or following corneal trauma. This syndrome is characterized by recurrent episodes of ocular pain more or less associated with localized separations between the outer epithelium and the epithelial basal lamina (basement membrane) because of anchorage abnormalities between these two corneal layers. This could be the result of an increased expression of metalloproteinases cleaving the hemidesmosomes which anchor epithelium to the basement membrane.\n\nThe investigators hypothesis is that episodes of RCEs are favored by a hyper- expression of matricial metalloprotease 9 (MMP-9) induced by EMMPRIN and Galectin-3. The identification of such induction could lead to development of therapeutics inhibiting EMMPRIN and Galectin- 3 in the RCE syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Recurrent Corneal Erosion Syndrome and control patients (undergoing photorefractive surgical keratectomy)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* Recurrent Corneal Erosion Syndrome, with - failure of medical treatment and therapeutic photokeratectomy scheduled\n* Photorefractive surgical keratectomy (control patients)\n\nExclusion Criteria:\n\n* Opposition to participation in the study\n* Known pregnancy or breast-feeding patient\n* No medical insurance coverage'}, 'identificationModule': {'nctId': 'NCT02891694', 'acronym': 'MERCURE', 'briefTitle': 'Metalloproteinases and Recurrent Corneal Erosion Syndrome', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'orgStudyIdInfo': {'id': 'EGN_2016_8'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'recurrent corneal erosion', 'interventionNames': ['Other: in vitro immuno-histo-chemical analysis of corneal epithelium']}, {'label': 'control patients (refractive surgery)', 'interventionNames': ['Other: in vitro immuno-histo-chemical analysis of corneal epithelium']}], 'interventions': [{'name': 'in vitro immuno-histo-chemical analysis of corneal epithelium', 'type': 'OTHER', 'armGroupLabels': ['control patients (refractive surgery)', 'recurrent corneal erosion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Fondation Opthalmologique A de Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Eric GABISON, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation OPH A de Rothschild'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}