Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-24 @ 5:59 AM
Study NCT ID:
NCT01889251
Status:
COMPLETED
Last Update Posted:
2015-11-30
First Post:
2013-06-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012607', 'term': 'Scotoma'}, {'id': 'D012167', 'term': 'Retinal Perforations'}], 'ancestors': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012164', 'term': 'Retinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C054561', 'term': 'microplasmin'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+81368995277', 'title': 'Group Manager, Clinical Development', 'organization': 'Alcon Japan, Ltd.'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected for the duration of the study (1 year, 2 months). This analysis group includes all subjects who received study medication, as treated. Note: One subject randomized to Ocriplasmin was inadvertently treated with Sham.', 'description': 'An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Ocular adverse events are presented for both study eye and non-study eye.', 'eventGroups': [{'id': 'EG000', 'title': 'Ocriplasmin', 'description': 'Single intravitreal injection to the study eye at baseline', 'otherNumAtRisk': 114, 'otherNumAffected': 63, 'seriousNumAtRisk': 114, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Sham Injection', 'description': 'Single sham injection to the study eye at baseline', 'otherNumAtRisk': 58, 'otherNumAffected': 19, 'seriousNumAtRisk': 58, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Anterior chamber cell', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Corneal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}], 'seriousEvents': [{'term': 'Macular hole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Vitreous adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Ocular hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Angle closure glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA/J (16.0)'}, {'term': 'Macular pseudohole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA/J (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocriplasmin', 'description': 'Single intravitreal injection to the study eye at baseline'}, {'id': 'OG001', 'title': 'Sham Injection', 'description': 'Single sham injection to the study eye at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '52.2', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all subjects who received study medication, completed at least 1 on-therapy study visit and had symptomatic VMA at baseline, as randomized, based on an intent to treat approach.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ocriplasmin', 'description': 'Single intravitreal injection to the study eye at baseline'}, {'id': 'FG001', 'title': 'Sham Injection', 'description': 'Single sham injection to the study eye at baseline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 40 study centers located in Japan.', 'preAssignmentDetails': 'Of the 251 enrolled, 79 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (172).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ocriplasmin', 'description': 'Single intravitreal injection to the study eye at baseline'}, {'id': 'BG001', 'title': 'Sham Injection', 'description': 'Single sham injection to the study eye at baseline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.1', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '68.6', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '68.2', 'spread': '8.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all randomized subjects, as randomized.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 251}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-02', 'studyFirstSubmitDate': '2013-06-26', 'resultsFirstSubmitDate': '2015-09-30', 'studyFirstSubmitQcDate': '2013-06-26', 'lastUpdatePostDateStruct': {'date': '2015-11-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-30', 'studyFirstPostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)', 'timeFrame': 'Day 28', 'description': 'VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitreomacular Adhesion', 'Vitreomacular Traction', 'Vitreomacular Traction Syndrome', 'Vitrectomy', 'Central Visual Field Defect', 'Blind Spot', 'Intravitreal Injection', 'Macula', 'Retina', 'Decreased Visual Acuity', 'Visual Complaint', 'SD-OCT', 'Macular Hole'], 'conditions': ['Symptomatic Vitreomacular Adhesion']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the superiority regarding vitreomacular adhesion (VMA) resolution of a single intravitreal injection of A01016 (Ocriplasmin) compared to sham-injection in subjects with symptomatic VMA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic vitreomacular adhesion (VMA) which, in the opinion of the Investigator, is related to decreased visual function;\n* Best corrected visual acuity (BCVA) of 20/25 or worse in the study eye;\n* BCVA of 20/800 or better in the non-study eye;\n* Provide written informed consent;\n* Follow specified instructions during study period;\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Evidence of proliferative retinopathy, exudative age-related macular degeneration, or retinal vein occlusion in the study eye;\n* Vitreous hemorrhage or other opacification;\n* High myopia in the study eye;\n* Ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior 3 months;\n* Uncontrolled glaucoma in the study eye;\n* History of retinal detachment in either eye;\n* Active infection in either eye;\n* Pregnant or of child-bearing potential and not utilizing acceptable form of contraception;\n* Participation in another investigational drug study within 30 days prior to this study;\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01889251', 'briefTitle': 'A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'A Phase III Study of A01016 125μg Intravitreal Injection in Subjects With Symptomatic Vitreomacular Adhesion - Comparison Study to Sham Injection', 'orgStudyIdInfo': {'id': 'J-12-075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ocriplasmin', 'description': 'Ocriplasmin administered as a single intravitreal injection to the study eye at baseline', 'interventionNames': ['Drug: Ocriplasmin']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham injection', 'description': 'Single sham injection to the study eye at baseline', 'interventionNames': ['Drug: Sham injection']}], 'interventions': [{'name': 'Ocriplasmin', 'type': 'DRUG', 'otherNames': ['A01016'], 'armGroupLabels': ['Ocriplasmin']}, {'name': 'Sham injection', 'type': 'DRUG', 'armGroupLabels': ['Sham injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Contact Alcon for Trial Locations', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Group Manager, Clinical Development', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Japan, Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}