Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-03-11 @ 1:02 AM
Study NCT ID:
NCT02091505
Status:
UNKNOWN
Last Update Posted:
2014-03-19
First Post:
2014-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Factors of Ranibizumab Treatment in Macular Edema With CRVO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012170', 'term': 'Retinal Vein Occlusion'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'lastUpdateSubmitDate': '2014-03-17', 'studyFirstSubmitDate': '2014-03-16', 'studyFirstSubmitQcDate': '2014-03-17', 'lastUpdatePostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best-corrected visual acuity', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Central Retinal Vein Occlusion']}, 'referencesModule': {'references': [{'pmid': '20381871', 'type': 'BACKGROUND', 'citation': 'Brown DM, Campochiaro PA, Singh RP, Li Z, Gray S, Saroj N, Rundle AC, Rubio RG, Murahashi WY; CRUISE Investigators. Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010 Jun;117(6):1124-1133.e1. doi: 10.1016/j.ophtha.2010.02.022. Epub 2010 Apr 9.'}, {'pmid': '23415775', 'type': 'BACKGROUND', 'citation': 'Bhisitkul RB, Campochiaro PA, Shapiro H, Rubio RG. Predictive value in retinal vein occlusions of early versus late or incomplete ranibizumab response defined by optical coherence tomography. Ophthalmology. 2013 May;120(5):1057-63. doi: 10.1016/j.ophtha.2012.11.011. Epub 2013 Feb 14.'}], 'seeAlsoLinks': [{'url': 'http://www.medic.mie-u.ac.jp/ophthalmology/', 'label': 'Department of Ophthalmology, Mie University Graduate School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'Recent studies have shown that intravitreal injection of anti-VEGF agent, Lucentis (Ranibizumab) is effective for macular edema associated with central retinal vein occlusion (CRVO). However, there is little information on whether there are any predictive factors of treatment outcome after this treatment. We plan to perform comprehensive functional and imaging tests to determine significant predictive factors.', 'detailedDescription': 'The purpose of the present study is to investigate predictive factors of treatment outcome after intravitreal injection of Lucentis (Ranibizumab) in eyes with macular edema associated with central retinal vein occlusion (CRVO) using various comprehensive clinical tests including visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, new flicker electroretinogram (ERG) using skin electrodes. Corrected visual acuity, visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, and new flicker electroretinogram (ERG) using skin electrodes are performed before and 3, 6, 9, 12 months after the treatment. Predictive factors of treatment outcome are statistically analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Macular edema associated with central retinal vein occlusion\n* Best corrected visual acuity \\< 20/30\n* Central macular thickness \\> 300\n* Period from symptom onset to treatment \\< 12 months\n\nExclusion Criteria:\n\n* Any past history of treatment for macular edema (e.g. anti-VEGF injection, steroid, vitrectomy)'}, 'identificationModule': {'nctId': 'NCT02091505', 'acronym': 'CRVO', 'briefTitle': 'Predictive Factors of Ranibizumab Treatment in Macular Edema With CRVO', 'organization': {'class': 'OTHER', 'fullName': 'Mie University'}, 'officialTitle': 'Predictive Factors of Treatment Outcome After Intravitreal Injection of Lucentis (Ranibizumab) in Eyes With Macular Edema Associated With Central Retinal Vein Occlusion (CRVO)', 'orgStudyIdInfo': {'id': 'MKONDO-CRVO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravitreal injection of Ranibizumab', 'interventionNames': ['Drug: Ranibizumab']}], 'interventions': [{'name': 'Ranibizumab', 'type': 'DRUG', 'armGroupLabels': ['Intravitreal injection of Ranibizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '514-8507', 'city': 'Tsu', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Mineo Kondo, MD. PhD.', 'role': 'CONTACT', 'email': 'mineo@clin.medic.mie-u.ac.jp', 'phone': '+81-59-231-5027'}], 'facility': 'Mie University Hospital'}], 'centralContacts': [{'name': 'Mineo Kondo, MD, PhD', 'role': 'CONTACT', 'email': 'mineo@clin.medic.mie-u.ac.jp', 'phone': '+81-59-231-5027'}], 'overallOfficials': [{'name': 'Mineo Kondo, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mie University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mie University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD. PhD.', 'investigatorFullName': 'Mineo Kondo', 'investigatorAffiliation': 'Mie University'}}}}