Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT01820520
Status:
TERMINATED
Last Update Posted:
2024-05-30
First Post:
2013-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012167', 'term': 'Retinal Perforations'}, {'id': 'D019773', 'term': 'Epiretinal Membrane'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C004692', 'term': 'coomassie Brilliant Blue'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'Undefined', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2013-03-26', 'studyFirstSubmitQcDate': '2013-03-27', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thickness of ganglion cell layer - inner plexiform layer measured by optical coherence tomography', 'timeFrame': '6 months', 'description': 'Average thickness of ganglion cell layer - inner plexiform layer measured by spectral domain optical coherence tomography'}, {'measure': 'Amplitude of pattern reversal electroretinogram', 'timeFrame': '6 months', 'description': 'Amplitude of pattern reversal electroretinogram (in microvolts)'}, {'measure': 'Amplitude of b-wave of multifocal electroretinogram', 'timeFrame': '6 months', 'description': 'Measurement of the amplitude of the b-wave of multifocal electroretinogram'}], 'secondaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '6 months', 'description': 'Visual acuity measured with an Early Treatment Diabetic Retinopathy Study chart'}, {'measure': 'Complications', 'timeFrame': '6 months', 'description': 'Presence of any ocular complication'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Macular Hole', 'Epiretinal Membrane']}, 'descriptionModule': {'briefSummary': 'Study designed to evaluate the safety and efficacy of double staining with brilliant blue G 0.025% as an adjuvant to macular surgery. Patients undergoing surgery for macular hole or epiretinal membrane will be included. Safety will be evaluated by optic coherence tomography, pattern reversal electroretinogram and multifocal electroretinogram.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age 18 years of older\n* Signing of informed consent\n* Macular pathology requiring vitrectomy (epiretinal membrane, macular hole, vitreomacular traction syndrome)\n\nExclusion Criteria:\n\n* Diagnosis of glaucoma\n* Known allergy to brilliant blue G'}, 'identificationModule': {'nctId': 'NCT01820520', 'briefTitle': 'Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Asociación para Evitar la Ceguera en México'}, 'officialTitle': 'Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery', 'orgStudyIdInfo': {'id': 'RE11-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Double staining with brilliant blue G during vitrectomy', 'interventionNames': ['Drug: brilliant blue G']}], 'interventions': [{'name': 'brilliant blue G', 'type': 'DRUG', 'description': 'Double staining with brilliant blue G 0.025% for macular surgery', 'armGroupLabels': ['Double staining with brilliant blue G during vitrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04030', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Asociación para Evitar la Ceguera en México', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asociación para Evitar la Ceguera en México', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}