Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-03 @ 7:52 AM
Study NCT ID:
NCT04676256
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2020-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012167', 'term': 'Retinal Perforations'}, {'id': 'D012163', 'term': 'Retinal Detachment'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-01-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2020-01-31', 'studyFirstSubmitQcDate': '2020-12-15', 'lastUpdatePostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of retinal detachment', 'timeFrame': '6 months after intervention', 'description': 'number of eyes with a retinal detachment in each group. The presence of retinal detachment will be assessed on fundus examination'}], 'secondaryOutcomes': [{'measure': 'Rate of retinal breaks', 'timeFrame': '6 months after intervention', 'description': 'number of eyes with a retinal breaks in each group. The presence of retinal breaks will be assessed on fundus examination'}, {'measure': 'Rate vitreo-retinal proliferation', 'timeFrame': '6 months after intervention', 'description': 'number of eyes with a vitreo-retinal proliferation in each group. The presence of vitreo-retinal proliferation will be assessed on fundus examination'}, {'measure': 'Visual acuity', 'timeFrame': '6 months after intervention', 'description': 'visual acuity will be measured using Snellen and/or ETDRS chart'}, {'measure': 'Rate of eyes with a loss of 5 letters or more', 'timeFrame': '6 months after intervention'}, {'measure': 'Rate of cataract', 'timeFrame': '6 months after intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spontaneous vitreous hemorrhage', 'retinal break', 'retinal detachment', 'ultrasound', 'vitrectomy'], 'conditions': ['Spontaneous Vitreous Hemorrhage', 'Retinal Break', 'Retinal Detachment']}, 'descriptionModule': {'briefSummary': 'The aim of the protocol is to compare the ocular outcomes after spontaneous vitreous hemorrhage treated with an early vitrectomy versus ultrasound monitoring with late vitrectomy.\n\nThe hypothesis is that an early vitrectomy could decrease the rate of retinal detachment occurring after a spontaneous vitreous hemorrhage.', 'detailedDescription': 'The aim of the protocol is to compare the ocular outcomes after spontaneous vitreous hemorrhage treated with an early vitrectomy versus ultrasound monitoring with late vitrectomy.\n\nThe hypothesis is that an early vitrectomy could decrease the rate of retinal detachment occurring after a spontaneous vitreous hemorrhage.\n\nScientific background Spontaneous vitreous hemorrhage may occur after spontaneous posterior vitreous detachment and causes retinal break and retinal detachment in about 70% and 40% of cases respectively. The fundus examination and ultrasound have limited sensitivity to detect retinal breaks in these cases. Some retrospective studies have highlighted the benefit of an early vitrectomy for decreasing the rate of visual loss due to retinal detachment in these cases. However, to date, there is no national or international consensus regarding the management of spontaneous vitreous hemorrhage and the timing of vitrectomy.\n\nStudy design Prospective randomized clinical trial Primary objective To compare the results of an early vitrectomy versus ultrasound and fundus observation in spontaneous vitreous hemorrhage.\n\nSecondary objectives To evaluate the rate of retinal complications in spontaneous vitreous hemorrhage treated either with early or delayed vitrectomy.\n\nTo evaluate the rate of visual loss in spontaneous vitreous hemorrhage treated either with early or delayed vitrectomy.\n\nPrimary criteria Rate of retinal detachment in eyes with spontaneous vitreous hemorrhage treated with early vitrectomy versus ultrasound observation at 6-month follow-up Secondary criteria Rate of retinal breaks and vitreo-retinal proliferation in eyes with spontaneous vitreous hemorrhage treated with early vitrectomy versus ultrasound observation at 6-month follow-up Visual acuity and rate of eyes with a loss of 5 letters or more among eyes with spontaneous vitreous hemorrhage treated with early vitrectomy versus ultrasound observation at 6-month follow-up Participants Patients with a spontaneous vitreous hemorrhage secondary to posterior vitreous detachment, with a reduced visibility of the fundus Inclusion criteria\n\n* Age \\> or = 18 years old\n* Spontaneous vitreous hemorrhage which is 1/ secondary to posterior vitreous detachment; 2/ acute: which duration is \\< 15 days, 3/ dense: reduced visibility of the fundus\n\nExclusion criteria:\n\n* Retinal detachment at the initial examination\n* Any history of vascular retinal disease (diabetic retinopathy, retinal vein occlusion…)\n* Any history of uveitis, age-related macular degeneration\n* History of a recent ocular traumatism (\\< 3 months)\n* History of a recent retinal laser treatment (\\< 3 months) or vitreo-retinal surgery (\\< 3 months)\n* Absence of consent Experimental group Eyes with spontaneous vitreous hemorrhage treated with early vitrectomy (n = 63) Active Comparator group Eyes with spontaneous vitreous hemorrhage only observed using fundus examination and B-ultrasound (n = 63) Study duration Inclusion: 12 months Participation: 6 months Total duration: 18 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> or = 18 years old\n* Spontaneous vitreous hemorrhage which is :\n\n 1. secondary to posterior vitreous detachment;\n 2. acute: which duration is \\< 15 days,\n 3. dense: reduced visibility of the fundus\n\nExclusion Criteria:\n\n* Retinal detachment at the initial examination\n* Any history of vascular retinal disease (diabetic retinopathy, retinal vein occlusion…)\n* Any history of uveitis, age-related macular degeneration\n* History of a recent ocular traumatism (\\< 3 months)\n* History of a recent retinal laser treatment (\\< 3 months) or vitreo-retinal surgery (\\< 3 months)\n* Absence of oral and written consent'}, 'identificationModule': {'nctId': 'NCT04676256', 'acronym': 'EVIDENSE', 'briefTitle': 'Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Comparaison de la Vitrectomie précoce et de la Surveillance Simple Dans la Prise en Charge Des hémorragies du vitré spontanées EVIDENSE Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage', 'orgStudyIdInfo': {'id': 'P170408J'}, 'secondaryIdInfos': [{'id': 'IDRCB', 'type': 'OTHER', 'domain': '2019-A019556-51'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Vitrectomy', 'description': 'Experimental arm will be treated with early vitrectomy early vitrectomy 7 days after vitreous hemorrhage diagnosis', 'interventionNames': ['Procedure: Early vitrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator', 'description': 'Active comparator arm will have fundus and ultrasound observation. Late vitrectomy may be indicated after 3 months of follow-up if needed.\n\nLate vitrectomy will be performed in case of persistant vitreous hemorrhage after 3 months of folllow-up', 'interventionNames': ['Procedure: Early vitrectomy']}], 'interventions': [{'name': 'Early vitrectomy', 'type': 'PROCEDURE', 'description': 'Eyes with spontaneous vitreous hemorrhage treated with early vitrectomy (n = 63)', 'armGroupLabels': ['Comparator', 'Early Vitrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aude Couturier, Dr', 'role': 'CONTACT', 'email': 'aude.couturier@aphp.fr', 'phone': '+33(0) 1.49.95.24.74'}], 'facility': 'Hopital Lariboisiere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Aude COUTURIER, MD, PhD', 'role': 'CONTACT', 'email': 'aude.couturier@aphp.fr', 'phone': '+33149952474'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}