Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-25 @ 3:04 PM
Study NCT ID:
NCT01914159
Status:
COMPLETED
Last Update Posted:
2019-08-15
First Post:
2013-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'krohne@uni-bonn.de', 'phone': '+49 228 287', 'title': 'Tim U. Krohne, MD, FEBO', 'phoneExt': '15505', 'organization': 'Dept of Ophthalmology, University of Bonn, Bonn, Germany'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ranibizumab', 'description': 'Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections', 'otherNumAtRisk': 24, 'otherNumAffected': 1, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Increase of subretinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Best-corrected Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': 'Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections'}], 'classes': [{'categories': [{'measurements': [{'value': '52.9', 'spread': '19.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol', 'unitOfMeasure': 'ETDRS letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Retinal Morphology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': 'Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections'}], 'classes': [{'categories': [{'measurements': [{'value': '436', 'spread': '171', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vision-related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': 'Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections'}], 'classes': [{'categories': [{'measurements': [{'value': '74.3', 'spread': '13.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'National Eye Institute Visual Function Questionaire 25-item version (NEI VFQ-25)\n\n0 to 100 scale, where 100 represents the best possible score and 0 represents the worst\n\nReference: Mangione CM et al. Arch Ophthalmol 2001 Jul;119(7):1050-8.', 'unitOfMeasure': 'NEI VFQ-25 score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ranibizumab', 'description': 'Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ranibizumab', 'description': 'Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76.8', 'spread': '5.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Best-corrected visual acuity', 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'spread': '18.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ETDRS letters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Central retinal thickness', 'classes': [{'categories': [{'measurements': [{'value': '571', 'spread': '185', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'µm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Vision-related quality of life', 'classes': [{'categories': [{'measurements': [{'value': '79.0', 'spread': '10.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'National Eye Institute Visual Function Questionaire 25-item version (NEI VFQ-25)\n\n0 to 100 scale, where 100 represents the best possible score and 0 represents the worst\n\nReference: Mangione CM et al. Arch Ophthalmol 2001 Jul;119(7):1050-8.', 'unitOfMeasure': 'NEI VFQ-25 score', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-03', 'studyFirstSubmitDate': '2013-07-28', 'resultsFirstSubmitDate': '2019-04-16', 'studyFirstSubmitQcDate': '2013-07-30', 'lastUpdatePostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-03', 'studyFirstPostDateStruct': {'date': '2013-08-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best-corrected Visual Acuity', 'timeFrame': '12 months', 'description': 'Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol'}], 'secondaryOutcomes': [{'measure': 'Retinal Morphology', 'timeFrame': '12 months', 'description': 'Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness'}, {'measure': 'Vision-related Quality of Life', 'timeFrame': '12 months', 'description': 'National Eye Institute Visual Function Questionaire 25-item version (NEI VFQ-25)\n\n0 to 100 scale, where 100 represents the best possible score and 0 represents the worst\n\nReference: Mangione CM et al. Arch Ophthalmol 2001 Jul;119(7):1050-8.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Age Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab (Lucentis, Novartis Pharma, Germany) on visual acuity and retinal morphology over a study period of 12 months in 30 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of a pigment epithelial tear secondary to age-related macular degeneration\n* Written informed consent\n\nExclusion Criteria:\n\n* Time of diagnosis more than 6 months before study recruitment\n* Ocular surgery of the study eye within 1 month before study recruitment\n* Extensive subretinal fibrosis or retinal atrophy of the study eye\n* Significant opacification of optical media of the study eye\n* Uncontrolled glaucoma of the study eye\n* Active ocular inflammation of the study eye\n* Best-corrected visual acuity of the contralateral eye below 20/200\n* Concurrent ocular or systemic therapy with other vascular endothelial growth factor (VEGF)-inhibitory drugs'}, 'identificationModule': {'nctId': 'NCT01914159', 'acronym': 'RIP', 'briefTitle': 'Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bonn'}, 'orgStudyIdInfo': {'id': 'N-037.0156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ranibizumab', 'interventionNames': ['Drug: Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)']}], 'interventions': [{'name': 'Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)', 'type': 'DRUG', 'description': 'Monthly intravitreal injections', 'armGroupLabels': ['Ranibizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'University of Bonn, Department of Ophthalmology', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '80336', 'city': 'München', 'country': 'Germany', 'facility': 'University of München (LMU), Department of Ophthalmology', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Universityof Münster, Department of Ophthalmology', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bonn', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Ophthalmology, University of Bonn', 'investigatorFullName': 'Frank G. Holz', 'investigatorAffiliation': 'University Hospital, Bonn'}}}}