Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-01-29 @ 8:44 AM
Study NCT ID:
NCT01448018
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2011-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion
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'}, {'id': 'D006438', 'term': 'Hemodilution'}], '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'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-12', 'studyFirstSubmitDate': '2011-09-29', 'studyFirstSubmitQcDate': '2011-10-05', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in visual acuity', 'timeFrame': '6 months', 'description': 'Change in best-corrected visual acuity (ETDRS chart) between baseline and 6 months'}], 'secondaryOutcomes': [{'measure': 'Gain in visual acuity of 2 ETDRS-lines or more', 'timeFrame': '6 months', 'description': 'Number of patients who gained 2 lines or more between baseline and the 6-month visit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Central Retinal Vein Occlusion']}, 'referencesModule': {'references': [{'pmid': '20953877', 'type': 'BACKGROUND', 'citation': 'Glacet-Bernard A, Atassi M, Fardeau C, Romanet JP, Tonini M, Conrath J, Denis P, Mauget-Faysse M, Coscas G, Soubrane G, Souied E. Hemodilution therapy using automated erythrocytapheresis in central retinal vein occlusion: results of a multicenter randomized controlled study. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):505-12. doi: 10.1007/s00417-010-1532-5. Epub 2010 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare ranibizumab injection to hemodilution at the early phase of Central Retinal Vein Occlusion (CRVO) and to determine if the combination of both treatments may have a synergic effect.', 'detailedDescription': 'Patients with recent-onset CRVO (lasting for less than 1 month)are randomly assigned to one of 3 groups: hemodilution using erythrocytapheresis alone, 3 monthly injection of ranibizumab alone, or both.\n\nPatients are followed monthly during the 6-month study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CRVO confirmed by fluorescein angiography\n* duration from onset of 1 month or less\n* visual acuity of 20/32 or less\n\nExclusion Criteria:\n\n* neovascular complication\n* extensive retinal ischemia requiring prompt panretinal photocoagulation\n* hematocrit level lower than 38%\n* previous laser or surgery in the study eye, etc'}, 'identificationModule': {'nctId': 'NCT01448018', 'acronym': 'CHIC-3', 'briefTitle': 'Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Pilot Study on Efficacy and Tolerance of Intravitreous Injection of Ranibizumab (Lucentis®) in Early-onset Central Retinal Vein Occlusion in Comparison to Hemodilution Using Erythrocytapheresis', 'orgStudyIdInfo': {'id': '2009-011403-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ranibizumab', 'description': 'patients in this arm receive 3 monthly injection of ranibizumab', 'interventionNames': ['Drug: ranibizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hemodilution', 'description': 'hemodilution using erythrocytapheresis is performed as early as possible after inclusion, in order to lessen hematocrit level (target hematocrit of 35%)', 'interventionNames': ['Procedure: hemodilution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ranibizumab and hemodilution', 'description': 'patients receive both treatments', 'interventionNames': ['Drug: ranibizumab', 'Procedure: hemodilution']}], 'interventions': [{'name': 'ranibizumab', 'type': 'DRUG', 'otherNames': ['Lucentis'], 'description': '3 monthly intravitreous injection as soon as possible after the inclusion', 'armGroupLabels': ['ranibizumab', 'ranibizumab and hemodilution']}, {'name': 'hemodilution', 'type': 'PROCEDURE', 'description': 'hemodilution using erythrocytapheresis - target hematocrit: 35% - as soon as possible after the inclusion', 'armGroupLabels': ['Hemodilution', 'ranibizumab and hemodilution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'Intercommunal Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Pitie-Salpetriere Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Agnes Glacet-Bernard', 'investigatorAffiliation': 'Centre Hospitalier Intercommunal Creteil'}}}}