Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-03-01 @ 6:37 PM
Study NCT ID:
NCT02874859
Status:
COMPLETED
Last Update Posted:
2021-02-05
First Post:
2016-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravitreal Aflibercept InjectiOn in Vitrectomized Eyes for Treatment of Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2016-08-17', 'studyFirstSubmitQcDate': '2016-08-17', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimation of visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS)', 'timeFrame': '96 weeks', 'description': 'Estimation of visual acuity after 96 weeks of treatment with Aflibercept'}], 'secondaryOutcomes': [{'measure': 'Measure of the central macular thickness', 'timeFrame': '96 weeks', 'description': 'Describe the evolution of the Central macular thickness during treatment'}, {'measure': 'Quantification of number of Aflibercept injections received', 'timeFrame': '96 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DIABETIC RETINOPATHY', 'Intravitreal aflibercept'], 'conditions': ['Diabetic Macular Edema']}, 'referencesModule': {'references': [{'pmid': '34007150', 'type': 'DERIVED', 'citation': 'Tran THC, Erginay A, Verdun S, Fourmaux E, Le Rouic JF, Uzzan J, Milazzo S, Baillif S, Kodjikian L. One-Year Outcome of Aflibercept Intravitreal Injection in Vitrectomized Eyes with Diabetic Macular Edema. Clin Ophthalmol. 2021 May 11;15:1971-1978. doi: 10.2147/OPTH.S304030. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'This a non-interventional retrospective study on the efficiency and the tolerance of intravitreal injections of Aflibercept on vitrectomized eyes in the diabetic macular oedema', 'detailedDescription': 'Diabetic macular edema (DME) is the leading cause of blindness among people of working age. Treatment of DME included blood pressure and glycemic control, grid laser, intravitreal injection of steroids (acetonide of triamcinolone, dexamethasone implant, fluocinolone implant) or anti-Vascular endothelial growth factor (VEGF) therapy (Bevacizumab, Ranibizumab, Aflibercept) (2015). The advent of anti-VEGF therapy has revolutionized the management of DME. Aflibercept, one of the drugs in this group has recently been approved in France. However, there is no report in the efficacy and tolerance of Aflibercept in vitrectomized eyes in the diabetic macular oedema . In this study, in order to prove the efficiency and tolerance of Aflibercept, data will be collected in a anonymous way in medical records of patients having received a treatment by Aflibercept in the past.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetic vitrectomised patients with macular edema, treated with Aflibercept in the past', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetic patients aged between 19 and 90 years old\n* Patients with the following characteristics at the beginning of the Aflibercept therapy :\n\nHbA1c \\< 9% Diabetic macular oedema with the central affected Visual acuity between 1/20 and 5/40 (between 20 and 70 letters ETRS) Patients who had a vitrectomy over 3 months ago\n\n* Patients who did not received an anti-VEGF treatment or any other treatment for their diabetic macular edema 3 months before the beginning of the injections\n\nExclusion Criteria:\n\n* Patients who refused the collection of their data in medical records\n* Patients with a macular ischemia of more than 1500µm diagnosed via an avascular central fluorescein angiography before the inclusion\n* Patients with a recent cardiovascular incident (heart attack, stroke dating for less than 3 months before the inclusion)\n* Pregnancy at the moment of inclusion'}, 'identificationModule': {'nctId': 'NCT02874859', 'acronym': 'MODEVA', 'briefTitle': 'Intravitreal Aflibercept InjectiOn in Vitrectomized Eyes for Treatment of Diabetic Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'Lille Catholic University'}, 'officialTitle': 'Aflibercept Injection for Treatment of Diabetic Macular Edema', 'orgStudyIdInfo': {'id': 'RC-P0051'}}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'Pr MILAZZO Solange', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '59160', 'city': 'Lomme', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'Tran Thi Ha Chau', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}, {'zip': '06001', 'city': 'Nice', 'state': 'PACA', 'country': 'France', 'facility': 'Stéphanie BAILLIF', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Dr DOMINGUEZ', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Pr KODJIKIAN', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '44300', 'city': 'Nantes', 'country': 'France', 'facility': 'Dr Franck BECQUET', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '76100', 'city': 'Rouen', 'country': 'France', 'facility': 'Dr UZZAN', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '75010', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Bénédicte DUPAS', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Thi Ha Chau TRAN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Groupement des Hôpitaux de l'Institut Catholique de Lille"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lille Catholic University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}