Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-02-13 @ 3:15 AM
Study NCT ID:
NCT01946451
Status:
UNKNOWN
Last Update Posted:
2013-09-19
First Post:
2013-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gene Expression in Patients With Epiretinal Membranes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-18', 'studyFirstSubmitDate': '2013-09-16', 'studyFirstSubmitQcDate': '2013-09-18', 'lastUpdatePostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gene expression in patients with idiopathic and secondary epiretinal membranes in proliferative diabetic retinopathy.', 'timeFrame': 'The period between the diagnosis of the ERMs and the actual surgery for the condition was between 2 and 43 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['idiopathic epiretinal membranes', 'secondary epiretinal membranes'], 'conditions': ['Proliferative Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate the expression of selected genes both in epiretinal membranes (ERMs) and peripheral blood mononuclear cells (PBMCs) from patients with primary and secondary epiretinal membranes in proliferative diabetic retinopathy. Possible correlations between messenger ribonucleic acid (mRNA) levels of these genes were also identified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population description:\n\nThe blood and ERM samples were obtained from patients treated in the Department of Ophthalmology, University Hospital No. 5, Medical University of Silesia, Katowice, Poland.\n\nAll subjects underwent a complete ophthalmic examination: best corrected visual acuity (BCVA), tonometry, slit lamp examination of anterior and posterior segment, optical coherence tomography (OCT) of the central retina.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian race,\n* both males and females,\n* aged ≥ 55 years,\n* suffering from idiopathic ERMs or secondary ERMs in proliferative diabetic retinopathy (PDR).\n* Presence of ERM was proven in optical coherence tomography (OCT) examination.\n\nExclusion criteria:\n\n* aged \\< 55 years,\n* systemic connective tissue disease,\n* active inflammatory process'}, 'identificationModule': {'nctId': 'NCT01946451', 'briefTitle': 'Gene Expression in Patients With Epiretinal Membranes', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Silesia'}, 'officialTitle': 'Gene Expression and Their Correlations in Patients With Idiopathic and Secondary Epiretinal Membranes in Proliferative Diabetic Retinopathy', 'orgStudyIdInfo': {'id': 'SilesianMU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Idiophatic ERMs'}, {'label': 'Secondary ERMs'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Katowice', 'country': 'Poland', 'facility': 'Medical University of Silesia', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Silesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dorota Romaniuk', 'investigatorAffiliation': 'Medical University of Silesia'}}}}