Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT02860858
Status:
COMPLETED
Last Update Posted:
2020-10-23
First Post:
2016-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2016-07-04', 'studyFirstSubmitQcDate': '2016-08-08', 'lastUpdatePostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected visual acuity (BCVA)', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Symtomatic Macular Polypoidal Choroidal Vasculopathy']}, 'descriptionModule': {'briefSummary': 'Objective: To evaluate the efficacy of intravitreal aflibercept injection on visual acuity in patients with symptomatic macular PCV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female \\>/= 18 years\n* Confirmed diagnosis of symptomatic macular PCV in the study eye defined by: - Active macular polypoidal lesions shown by ICGA and - Presence of serosanguinous maculopathy\n* BCVA letter score between 78-24 using ETDRS visual acuity chart measured at 4 meters\n\nExclusion Criteria:\n\n* Previous treatment with systemic anti-VEGF drugs within 6 months prior to Baseline (e.g., sorafenib \\[Nexavar®\\], sunitinib \\[Sutent®\\], bevacizumab \\[Avastin®\\])\n\nStudy eye:\n\n* Active ocular inflammation or infection (ocular or periocular)\n* Uncontrolled intraocular hypertension or glaucoma (IOP\\> 30 mmPIg) despite treatment with anti-glaucoma medication\n* Predominantly-scarred PCV lesions\n* Ocular disorders in the study eye (e.g. cataract, retinal vascular occlusion, diabetic retinopathy) that, in the opinion of the investigator may confound interpretation of study results or compromise VA or require medical or surgical intervention during the study period\n* Prior treatment with verteporfin PDT, external-beam radiation, subfoveal or extrafoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy\n* Prior treatment with any anti-VEGF compound or any investigational treatment\n* Treatment with intravitreal or subtenon corticosteroid injection or device implantation within 90 days'}, 'identificationModule': {'nctId': 'NCT02860858', 'briefTitle': 'Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Department of Medical Services Ministry of Public Health of Thailand'}, 'officialTitle': 'Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)', 'orgStudyIdInfo': {'id': '18265_CREC032/59BPs'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aflibercept', 'interventionNames': ['Biological: Intravitreous aflibercept injection']}], 'interventions': [{'name': 'Intravitreous aflibercept injection', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Aflibercept']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Rajavithi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Department of Medical Services Ministry of Public Health of Thailand', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}