Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-26 @ 1:20 PM
Study NCT ID:
NCT04395859
Status:
COMPLETED
Last Update Posted:
2022-03-03
First Post:
2020-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collateral Damage From the COVID-19 Pandemic Observed in Patients Treated With Intravitreal Injections (IVT) of Anti-angiogenic Agents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012170', 'term': 'Retinal Vein Occlusion'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'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'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 233}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-02', 'studyFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2020-05-19', 'lastUpdatePostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of visual acuity in patients treated with repeated IVT anti-angiogens during the COVID-19 epidemic', 'timeFrame': 'Baseline (Before confinement) and 6 months after resumption of follow-up', 'description': 'Change from baseline (last visual acuity before confinement) and visual acuity 6 months after resumption of follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intravitreal Injections', 'Anti-angiogenics', 'COVID19'], 'conditions': ['Age Related Macular Degeneration', 'Diabetic Macular Edema', 'Retinal Vein Occlusion']}, 'referencesModule': {'references': [{'pmid': '37024478', 'type': 'DERIVED', 'citation': 'Sukkarieh G, Bonnin S, Azar G, Lafolie J, Alonso AS, Erol O, Pineau J, Villain H, Guillaume J, Auge E, Mingou A, Lejoyeux R, Vasseur V, Mauget-Faysse M. Outcome of Patients Treated by Intravitreal Injections During the COVID-19 Lockdown: An Institutional Experience. Curr Eye Res. 2023 Jul;48(7):683-689. doi: 10.1080/02713683.2023.2200564. Epub 2023 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'In patients treated for exudative age-related macular degeneration (AMD), diabetes, retinal venous occlusion (OVR), or other conditions causing macular edema, treatments with anti-angiogenic intravitreal injections (IVT) are widely used both for their anti-angiogenic action. Patients often have injections for many years, sometimes monthly or every 2 months.\n\nThe discontinuation of treatment with repeated injections of anti-angiogenic agents, linked to the COVID-19 coronavirus pandemic will potentially impact the visual acuity, the ophthalmological state and the quality of life of the patients concerned, therefore it is relevant to analyze the consequences the breakdown of usual care in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with repeated IVT treatment of anti-angiogenic drugs', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ocular pathology requiring repeated IVT treatment of anti-angiogenic drugs (exudative AMD, diabetic macular edema or secondary to retinal venous occlusion ...)\n* Beginning of IVT treatment repeated before 10/01/2019 (6 months before the start of French confinement)\n\nExclusion Criteria:\n\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT04395859', 'acronym': 'COVIDIV', 'briefTitle': 'Collateral Damage From the COVID-19 Pandemic Observed in Patients Treated With Intravitreal Injections (IVT) of Anti-angiogenic Agents', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Collateral Damage From the COVID-19 Pandemic Observed in Patients Treated With Intravitreal Injections (IVT) of Anti-angiogenic Agents', 'orgStudyIdInfo': {'id': 'MMT_2020_15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated with IVT before COVID19 pandemia', 'description': 'Treatment started at least 6 months before the French confinement for COVID19 (15th march 2020)', 'interventionNames': ['Procedure: Questionnaire', 'Other: Data collection up to 1 year']}], 'interventions': [{'name': 'Questionnaire', 'type': 'PROCEDURE', 'description': 'At inclusion : Questionnaire collecting data concerning the interruption of IVT treatment', 'armGroupLabels': ['Patients treated with IVT before COVID19 pandemia']}, {'name': 'Data collection up to 1 year', 'type': 'OTHER', 'description': 'Data collection up to 1 year after resumption of follow-up: visual acuity, OCT : optical coherence tomography, IVT treatment, complications', 'armGroupLabels': ['Patients treated with IVT before COVID19 pandemia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Écully', 'country': 'France', 'facility': "Centre Pôle Vision du val d'Ouest", 'geoPoint': {'lat': 45.77437, 'lon': 4.77758}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Fondation Adolphe de Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Centre ophtalmologique Maison Rouge', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Martine MAUGET FAYSSE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Adolphe de Rothschild'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}