Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-03-06 @ 9:34 AM
Study NCT ID:
NCT02015351
Status:
COMPLETED
Last Update Posted:
2022-01-05
First Post:
2013-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravitreal Bevacizumab for the Treatment of CNV in VKH Disease - A Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020256', 'term': 'Choroidal Neovascularization'}, {'id': 'D014607', 'term': 'Uveomeningoencephalitic Syndrome'}], 'ancestors': [{'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-04', 'studyFirstSubmitDate': '2013-12-05', 'studyFirstSubmitQcDate': '2013-12-12', 'lastUpdatePostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity change', 'timeFrame': '6 months', 'description': 'Visual Acuity will be measured using Snellen charts with best refraction by the same examiner.'}, {'measure': 'Change in central foveal thickness', 'timeFrame': '6 months', 'description': "Central foveal thickness will be measured manually using the caliper by the same examiner. Measurements will be proceeded from the Bruch's membrane till the internal limiting membrane and comparison with previous measurement will be done."}, {'measure': 'Presence or absence of intra/subretinal fluid in OCT', 'timeFrame': '6 months', 'description': 'OCT will be analyzed at 6 and 12 months for the presence of intra or subretinal fluid.'}], 'secondaryOutcomes': [{'measure': 'Visual Acuity change', 'timeFrame': '12 months', 'description': 'Visual Acuity will be measured using Snellen charts with best refraction by the same examiner.'}, {'measure': 'Change in Central Foveal Thickness', 'timeFrame': '12 months', 'description': "Central foveal thickness will be measured manually using the caliper by the same examiner. Measurements will be proceeded from the Bruch's membrane till the internal limiting membrane and comparison with previous measurement will be done."}, {'measure': 'Presence or Absence of Intra/Subretinal fluid in OCT', 'timeFrame': '12 months', 'description': 'OCT will be analyzed at 6 and 12 months for the presence of intra or subretinal fluid.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Choroidal neovascularization', 'Vogt Koyanagi Harada Disease', 'Inflammatory choroidal neovascularization', 'Anti-VEGF'], 'conditions': ['Choroidal Neovascularization']}, 'referencesModule': {'references': [{'pmid': '16019682', 'type': 'RESULT', 'citation': 'Perentes Y, Van Tran T, Sickenberg M, Herbort CP. Subretinal neovascular membranes complicating uveitis: frequency, treatments, and visual outcome. Ocul Immunol Inflamm. 2005 Apr-Jun;13(2-3):219-24. doi: 10.1080/09273940490518883.'}, {'pmid': '21358461', 'type': 'RESULT', 'citation': 'Rouvas A, Petrou P, Douvali M, Ntouraki A, Vergados I, Georgalas I, Markomichelakis N. Intravitreal ranibizumab for the treatment of inflammatory choroidal neovascularization. Retina. 2011 May;31(5):871-9. doi: 10.1097/IAE.0b013e3182003ca8.'}, {'pmid': '18046222', 'type': 'RESULT', 'citation': 'Adan A, Mateo C, Navarro R, Bitrian E, Casaroli-Marano RP. Intravitreal bevacizumab (avastin) injection as primary treatment of inflammatory choroidal neovascularization. Retina. 2007 Nov-Dec;27(9):1180-6. doi: 10.1097/IAE.0b013e31815e9834.'}, {'pmid': '19184312', 'type': 'RESULT', 'citation': 'Wu L, Evans T, Saravia M, Schlaen A, Couto C. Intravitreal bevacizumab for choroidal neovascularization secondary to Vogt-Koyanagi-Harada syndrome. Jpn J Ophthalmol. 2009 Jan;53(1):57-60. doi: 10.1007/s10384-008-0600-4. Epub 2009 Jan 30.'}, {'pmid': '21826150', 'type': 'RESULT', 'citation': 'Kolomeyer AM, Roy MS, Chu DS. The use of intravitreal ranibizumab for choroidal neovascularization associated with vogt-koyanagi-harada syndrome. Case Rep Med. 2011;2011:747648. doi: 10.1155/2011/747648. Epub 2011 Aug 3.'}, {'pmid': '18682970', 'type': 'RESULT', 'citation': 'Tran TH, Fardeau C, Terrada C, Ducos De Lahitte G, Bodaghi B, Lehoang P. Intravitreal bevacizumab for refractory choroidal neovascularization (CNV) secondary to uveitis. Graefes Arch Clin Exp Ophthalmol. 2008 Dec;246(12):1685-92. doi: 10.1007/s00417-008-0906-4. Epub 2008 Aug 6.'}, {'pmid': '16687455', 'type': 'RESULT', 'citation': 'Nowilaty SR, Bouhaimed M; Photodynamic Therapy Study Group. Photodynamic therapy for subfoveal choroidal neovascularisation in Vogt-Koyanagi-Harada disease. Br J Ophthalmol. 2006 Aug;90(8):982-6. doi: 10.1136/bjo.2006.091538. Epub 2006 May 10.'}, {'pmid': '19427992', 'type': 'RESULT', 'citation': 'Mansour AM, Arevalo JF, Ziemssen F, Mehio-Sibai A, Mackensen F, Adan A, Chan WM, Ness T, Banker AS, Dodwell D, Chau Tran TH, Fardeau C, Lehoang P, Mahendradas P, Berrocal M, Tabbarah Z, Hrisomalos N, Hrisomalos F, Al-Salem K, Guthoff R. Long-term visual outcomes of intravitreal bevacizumab in inflammatory ocular neovascularization. Am J Ophthalmol. 2009 Aug;148(2):310-316.e2. doi: 10.1016/j.ajo.2009.03.023. Epub 2009 May 9.'}]}, 'descriptionModule': {'briefSummary': 'Efficacy of monthly intravitreal anti-vascular endothelial growth factor (VEGF) associated to systemic immunosuppression in patients with Vogt-Koyanagi-Harada Disease and choroidal neovascularization. Minimum follow-up 12 months. Endpoints: 6 and 12 months of follow-up. Outcome measures: improvement of VA, decrease in central foveal thickness as measured by Optical Coherence Tomography (OCT) and absence of intra/subretinal fluid.', 'detailedDescription': 'Choroidal neovascularization (CNV) in Vogt-Koyanagi-Harada (VKH) disease is associated with poor visual prognosis. Several treatments have been suggested, though there is still no standard therapy. CNV diagnosis will be based on fundus biomicroscopy (presence of serous retinal detachment with or without retinal hemorrhages), fluorescein angiography (FA) (presence of early phase hyperfluorescence with late phase leakage) and OCT findings (hyperreflective lesion related to a CNV complex with serous foveal detachment or intraretinal fluid with increased foveal thickness). Inflammation will be considered active if anterior chamber cells or optic disc leakage in FA is observed. Each patient will undergo a complete clinical exam, including best corrected visual acuity (VA) (Snellen charts). Once active CNV is identified, a loading dose of 3 injections of IV bevacizumab will be proceeded monthly and systemic immunosuppression will be introduced or intensified. After the first 3 injections, the patient will be clinically examined and OCT will be proceeded monthly. The persistence of intra/subretinal fluid in the OCT will indicate one more IV bevacizumab injection. Immunosuppression status evaluation will be done at 3, 6, 9 and 12 months of follow up and intensification will be done if inflammatory signs or persistence of intraretinal fluid is observed. Presence of intra/subretinal fluid and manual measurement of retina central foveal thickness (CFT) will be proceeded in horizontal scan by the same examiner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with Vogt-Koyanagi-Harada disease based on Revised Diagnostic Criteria presented by the International Committee on VKH disease in 2001;\n2. Presence of choroidal neovascularization identified by fundus biomicroscopy, fluorescein angiography and OCT.\n\nExclusion Criteria:\n\n* Media opacities precluding posterior segment exam, ametropia over 5 dioptries, glaucoma (defined as a disease with characteristic damage at the optic nerve or characteristic visual field defect with compatible nerve fiber layer lesion), Age related Macular degeneration, impossibility to increase immunosuppression.'}, 'identificationModule': {'nctId': 'NCT02015351', 'briefTitle': 'Intravitreal Bevacizumab for the Treatment of CNV in VKH Disease - A Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization in Vogt-Koyanagi-Harada Disease - A Prospective Study', 'orgStudyIdInfo': {'id': 'Brazilian VKH Study Group'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anti-VEGF and Immunosuppression', 'description': 'Bevacizumab: Dosage 1.25mg/0.05ml; Frequency monthly injections; Duration at least 3 months.\n\nImmunosuppression: cyclosporine and/or azathioprine', 'interventionNames': ['Drug: bevacizumab']}], 'interventions': [{'name': 'bevacizumab', 'type': 'DRUG', 'otherNames': ['Bevacizumab (Avastin;Genentech Inc,USA)'], 'description': 'Injection technique: After lid speculum insertion and irrigation of the conjunctiva with 5% povidone-iodine, 0,05ml of bevacizumab will be inserted through the pars plana 3.5mm to 4.0mm posterior to the surgical limbus using a 30 gauge needle. After injection, topical antibiotics will be immediately applied in the injected eye. Immunosuppression: Corticosteroids will be prescribed (1mg/Kg/d) with tapering along 5 months. Immunosuppressive drug of choice is cyclosporine (3-5mg/Kg/d). In case of contraindication to cyclosporine use, azathioprine or mycophenolate mofetil will be prescribed.', 'armGroupLabels': ['Anti-VEGF and Immunosuppression']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clínicas- University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Joyce H Yamamoto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo School of Medicine Ophthalmology'}, {'name': 'Viviane M Sakata, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Coordinator of the Uveitis Service', 'investigatorFullName': 'Joyce Hisae Yamamoto', 'investigatorAffiliation': 'University of Sao Paulo'}}}}