Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-05 @ 5:21 PM
Study NCT ID:
NCT01710332
Status:
COMPLETED
Last Update Posted:
2017-06-16
First Post:
2012-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Safety & Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056833', 'term': 'Central Serous Chorioretinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mformoso@midatlanticretina.com', 'phone': '215-459-0477', 'title': 'Allen C. Ho, MD', 'organization': 'Mid Atlantic Retina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intravitreal Aflibercept Injection (x4)', 'description': '2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).\n\nIntravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intravitreal Aflibercept Injection (x6)', 'description': '2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).\n\nGROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety of Intravitreal Aflibercept Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravitreal Aflibercept Injection (x4)', 'description': '2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).\n\nIntravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).'}, {'id': 'OG001', 'title': 'Intravitreal Aflibercept Injection (x6)', 'description': '2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).\n\nGROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Vision Based on Letter Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravitreal Aflibercept Injection (x4)', 'description': '2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).\n\nIntravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).'}, {'id': 'OG001', 'title': 'Intravitreal Aflibercept Injection (x6)', 'description': '2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).\n\nGROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '13.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': '• Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score', 'unitOfMeasure': 'ETDRS letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intravitreal Aflibercept Injection (x4)', 'description': '2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).\n\nIntravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).\n\nGROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).'}, {'id': 'FG001', 'title': 'Intravitreal Aflibercept Injection (x6)', 'description': '2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).\n\nIntravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).\n\nGROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intravitreal Aflibercept Injection (x4)', 'description': '2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).\n\nIntravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).\n\nGROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).'}, {'id': 'BG001', 'title': 'Intravitreal Aflibercept Injection (x6)', 'description': '2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).\n\nIntravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).\n\nGROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '53.5', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '53.7', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-22', 'studyFirstSubmitDate': '2012-10-16', 'resultsFirstSubmitDate': '2017-02-22', 'studyFirstSubmitQcDate': '2012-10-18', 'lastUpdatePostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-22', 'studyFirstPostDateStruct': {'date': '2012-10-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of Intravitreal Aflibercept Injection', 'timeFrame': '6 months', 'description': 'Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.'}], 'secondaryOutcomes': [{'measure': 'Change in Vision Based on Letter Score', 'timeFrame': '6 months', 'description': '• Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Persistent', 'Central', 'Serous', 'Chorioretinopathy', 'Regeneron', 'CSR', 'CSCR'], 'conditions': ['Central Serous Chorioretinopathy']}, 'referencesModule': {'references': [{'pmid': '40522203', 'type': 'DERIVED', 'citation': 'Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3.'}, {'pmid': '25595177', 'type': 'DERIVED', 'citation': 'Pitcher JD 3rd, Witkin AJ, DeCroos FC, Ho AC. A prospective pilot study of intravitreal aflibercept for the treatment of chronic central serous chorioretinopathy: the CONTAIN study. Br J Ophthalmol. 2015 Jun;99(6):848-52. doi: 10.1136/bjophthalmol-2014-306018. Epub 2015 Jan 16.'}]}, 'descriptionModule': {'briefSummary': 'A preliminary study to determine the safety and efficacy of intravitreal aflibercept injection in patients with persistent central serous chorioretinopathy.', 'detailedDescription': 'Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-treatment acuity of 20/40- 20/320\n* Macular fluid on optical coherence tomography for greater than 3 months\n* Leakage on fluorescein angiography\n* Willing and able to comply with clinic visits and study-related procedures\n* Provide signed informed consent\n\nExclusion Criteria:\n\n* Treatment for CSCR in the study eye (anti-VEGF, PDT, or laser) within three months prior to study enrollment\n* Presence of choroidal neovascularization on enrollment imaging\n* Prior vitrectomy in the study eye\n* Presence of any substantial ocular disease (other than CSCR) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, ocular vascular occlusion, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.\n* History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye\n* Uncontrolled glaucoma in the study eye (defined as IOP ≥ 25 mmHg despite treatment with anti-glaucoma medication)\n* Active ocular infection or inflammation in the study eye\n* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye\n* Prior treatment with systemic anti-VEGF agents\n* Cerebrovascular accident or myocardial infarction within the preceding 6 months.\n* History of allergy to fluorescein, povidone iodine (Betadine) or aflibercept\n* Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study\n* Pregnant or breast-feeding women Sexually active men\\* or women of childbearing potential\\*\\* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device \\[IUD\\]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)\n\n * Contraception is not required for men with documented vasectomy.\n\n * Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.'}, 'identificationModule': {'nctId': 'NCT01710332', 'acronym': 'CONTAIN', 'briefTitle': 'The Safety & Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Wills Eye'}, 'officialTitle': 'Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study', 'orgStudyIdInfo': {'id': 'CSRII'}, 'secondaryIdInfos': [{'id': '20121564', 'type': 'OTHER', 'domain': 'Western IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravitreal Aflibercept Injection (x4)', 'description': '2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).', 'interventionNames': ['Drug: Intravitreal Aflibercept Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Intravitreal Aflibercept Injection (x6)', 'description': '2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).', 'interventionNames': ['Drug: Intravitreal Aflibercept Injection']}], 'interventions': [{'name': 'Intravitreal Aflibercept Injection', 'type': 'DRUG', 'otherNames': ['Eylea'], 'description': 'GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).\n\nGROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).', 'armGroupLabels': ['Intravitreal Aflibercept Injection (x4)', 'Intravitreal Aflibercept Injection (x6)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19006', 'city': 'Huntingdon Valley', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mid Atlantic Retina- Huntingdon Valley', 'geoPoint': {'lat': 40.12261, 'lon': -75.0635}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mid Atlantic Retna- Wills Eye Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Allen Ho, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wills Eye', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Allen C. Ho, MD', 'investigatorAffiliation': 'Wills Eye'}}}}