- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02015351
Intravitreal Bevacizumab for the Treatment of CNV in VKH Disease - A Prospective Study
4. januar 2022 opdateret af: Joyce Hisae Yamamoto, University of Sao Paulo
Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization in Vogt-Koyanagi-Harada Disease - A Prospective Study
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
9
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Sao Paulo, Brasilien
- Hospital das Clínicas- University of Sao Paulo
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
10 år til 70 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients diagnosed with Vogt-Koyanagi-Harada disease based on Revised Diagnostic Criteria presented by the International Committee on VKH disease in 2001;
- Presence of choroidal neovascularization identified by fundus biomicroscopy, fluorescein angiography and OCT.
Exclusion Criteria:
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Anti-VEGF and Immunosuppression
Bevacizumab: Dosage 1.25mg/0.05ml; Frequency monthly injections; Duration at least 3 months. Immunosuppression: cyclosporine and/or azathioprine |
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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Visual Acuity change
Tidsramme: 6 months
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Visual Acuity will be measured using Snellen charts with best refraction by the same examiner.
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6 months
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Change in central foveal thickness
Tidsramme: 6 months
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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.
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6 months
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Presence or absence of intra/subretinal fluid in OCT
Tidsramme: 6 months
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OCT will be analyzed at 6 and 12 months for the presence of intra or subretinal fluid.
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6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Visual Acuity change
Tidsramme: 12 months
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Visual Acuity will be measured using Snellen charts with best refraction by the same examiner.
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12 months
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Change in Central Foveal Thickness
Tidsramme: 12 months
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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.
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12 months
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Presence or Absence of Intra/Subretinal fluid in OCT
Tidsramme: 12 months
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OCT will be analyzed at 6 and 12 months for the presence of intra or subretinal fluid.
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12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Joyce H Yamamoto, MD, University of Sao Paulo School of Medicine Ophthalmology
- Ledende efterforsker: Viviane M Sakata, MD, University of Sao Paulo
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2012
Primær færdiggørelse (Faktiske)
1. oktober 2017
Studieafslutning (Faktiske)
1. oktober 2018
Datoer for studieregistrering
Først indsendt
5. december 2013
Først indsendt, der opfyldte QC-kriterier
12. december 2013
Først opslået (Skøn)
19. december 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. januar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. januar 2022
Sidst verificeret
1. januar 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Øjensygdomme
- Uveal Sygdomme
- Choroid sygdomme
- Metaplasi
- Choroidal neovaskularisering
- Neovaskularisering, patologisk
- Lægemidlers fysiologiske virkninger
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Bevacizumab
Andre undersøgelses-id-numre
- Brazilian VKH Study Group
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Choroidal neovaskularisering
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Groupe Hospitalier Paris Saint JosephAfsluttet
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Cairo UniversityAfsluttet
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Asociación para Evitar la Ceguera en MéxicoCentro Medico IssemymUkendtSubfoveal choroidal neovaskulariseringMexico
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Novartis PharmaceuticalsRekrutteringMakula polypoid choroidal vaskulopati (PCV)Korea, Republikken
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