Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-02-10 @ 10:05 PM
Study NCT ID:
NCT02151695
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2014-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2014-05-28', 'studyFirstSubmitQcDate': '2014-05-29', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with regression of retinal neovascularization between baseline and 12th month.', 'timeFrame': '12 months'}]}, 'conditionsModule': {'conditions': ['Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'Proliferative diabetic retinopathy is a serious complication of diabetes mellitus, partly consecutive to upregulation of vascular endothelial growth factor (VEGF) as a consequence of retinal ischemia leads. Aflibercept has been approved by FDA and European medicine agency for treatment of exudative age-related macular degeneration, another retinal disease characterized by choroidal new vessels.\n\nThe aim of this pilot study is to evaluate the efficacy and the safety of Aflibercept intravitreal injections compared to panretinal photocoagulation for proliferative diabetic retinopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diabetes mellitus type 1 or type 2 complicated by PDR\n* Male or female over 18 years\n* HbA1c \\<11.6% at study entry\n* Systolic blood pressure \\<160 mmHg and diastolic blood pressure \\<105 mmHg at study entry\n* Backgrounds clear eye, pupil dilation and patient cooperation sufficient to allow examination or fundus photographs of good quality\n\nExclusion Criteria:\n\n* Hypersensitivity to aflibercept or to any of the excipients\n* History of retinal laser (macular or panretinal photocoagulation), of intravitreal injections, of vitrectomy in the eye studied\n* PDR associated with tractional retinal detachment in the eye studied\n* PDR associated with fibrovascular proliferation in the eye studied\n* Florid diabetic retinopathy\n* Eye infection or periocular active or suspected\n* Unbalanced glaucoma in the eye studied\n* Other eye disease in the eye studied\n* Patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied'}, 'identificationModule': {'nctId': 'NCT02151695', 'briefTitle': 'Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Phase 2 Study of Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.', 'orgStudyIdInfo': {'id': 'mEdICARE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Panretinal photocoagulation', 'interventionNames': ['Procedure: panretinal photocoagulation']}, {'type': 'EXPERIMENTAL', 'label': 'Aflibercept intravitreal injections', 'interventionNames': ['Drug: Aflibercept intravitreal injections']}], 'interventions': [{'name': 'panretinal photocoagulation', 'type': 'PROCEDURE', 'armGroupLabels': ['Panretinal photocoagulation']}, {'name': 'Aflibercept intravitreal injections', 'type': 'DRUG', 'armGroupLabels': ['Aflibercept intravitreal injections']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Poitiers', 'country': 'France', 'facility': 'Chu de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'overallOfficials': [{'name': 'Nicolas LEVEZIEL, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poitiers University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}