Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2026-02-22 @ 7:01 AM
Study NCT ID:
NCT01238393
Status:
COMPLETED
Last Update Posted:
2016-01-13
First Post:
2010-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Epiretinal Membranes With Ranibizumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019773', 'term': 'Epiretinal Membrane'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-12', 'studyFirstSubmitDate': '2010-11-09', 'studyFirstSubmitQcDate': '2010-11-09', 'lastUpdatePostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of improvement measured by optical coherence tomography', 'timeFrame': '3 and 6 months'}], 'secondaryOutcomes': [{'measure': 'Distance visual acuity (ETDRS)', 'timeFrame': '3 and 6 months'}, {'measure': 'Near visual acuity (Snellen)', 'timeFrame': '3 and 6 months'}, {'measure': 'Subjective change in symptoms', 'timeFrame': '3 and 6 months'}, {'measure': 'Amsler grid improvement', 'timeFrame': '3 and 6 months'}, {'measure': 'Quality of life improvement', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Epiretinal Membrane']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether intraocular injection of ranibizumab decreases the retinal thickness in patients with epiretinal membranes and reduces associated symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic idiopathic epiretinal membrane\n\nExclusion Criteria:\n\n* vision worse than 6/18 and fit for surgery\n* prior vitreoretinal surgery or injection\n* diabetes\n* any past or current form of retinal vein occlusion or neovascularization\n* age-related macular degeneration\n* other condition causing significant limitation of visual potential'}, 'identificationModule': {'nctId': 'NCT01238393', 'acronym': 'LERM', 'briefTitle': 'Treatment of Epiretinal Membranes With Ranibizumab', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'A Prospective Pilot Study of Lucentis for Epiretinal Membranes: the LERM Study', 'orgStudyIdInfo': {'id': 'OPTH-092-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ranibizumab', 'description': "('intravitreal ranibizumab' )", 'interventionNames': ['Drug: intravitreal ranibizumab']}], 'interventions': [{'name': 'intravitreal ranibizumab', 'type': 'DRUG', 'otherNames': ['Lucentis'], 'description': 'monthly injections x3 +/- 2nd series of 3', 'armGroupLabels': ['Ranibizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 5G2', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Queen's University, Hotel Dieu Hospital", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'Jeffrey Gale, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}