Intravitreal Bevacizumab for the Treatment of CNV in VKH Disease - A Prospective Study

NCT02015351 | Completed

• 1 other identifier: Brazilian VKH Study Group
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Choroidal Neovascularization

Keywords

Choroidal neovascularization; Vogt Koyanagi Harada Disease; Inflammatory choroidal neovascularization; Anti-VEGF

Outcome Measures

Primary Outcomes (3)

• Visual Acuity change

  Visual Acuity will be measured using Snellen charts with best refraction by the same examiner.

  6 months

• Change in central foveal thickness

  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.

  6 months

• Presence or absence of intra/subretinal fluid in OCT

  OCT will be analyzed at 6 and 12 months for the presence of intra or subretinal fluid.

  6 months

Secondary Outcomes (3)

• Visual Acuity change

  12 months

• Change in Central Foveal Thickness

  12 months

• Presence or Absence of Intra/Subretinal fluid in OCT

  12 months

Study Arms (1)

Anti-VEGF and Immunosuppression

EXPERIMENTAL

Bevacizumab: Dosage 1.25mg/0.05ml; Frequency monthly injections; Duration at least 3 months. Immunosuppression: cyclosporine and/or azathioprine

Drug: bevacizumab

Interventions

bevacizumab DRUG

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.

Also known as: Bevacizumab (Avastin;Genentech Inc,USA)

Anti-VEGF and Immunosuppression

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Hospital das Clínicas- University of Sao Paulo

São Paulo, Brazil

Location

Related Publications (8)

• 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: 16019682 RESULT

• 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: 21358461 RESULT

• 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: 18046222 RESULT

• 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: 19184312 RESULT

• 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: 21826150 RESULT

• 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: 18682970 RESULT

• 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: 16687455 RESULT

• 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.

  PMID: 19427992 RESULT

MeSH Terms

Conditions

Choroidal Neovascularization; Uveomeningoencephalitic Syndrome

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Uveitis; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Joyce H Yamamoto, MD

  University of Sao Paulo School of Medicine Ophthalmology

  PRINCIPAL INVESTIGATOR

• Viviane M Sakata, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Coordinator of the Uveitis Service

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 19, 2013
• Study Start: September 1, 2012
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: January 5, 2022

Record last verified: 2022-01

Locations

BR (1)