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

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ClinicalTrials.gov Identifier: NCT02015351
Recruitment Status : Unknown
Verified December 2013 by Joyce Hisae Yamamoto, University of Sao Paulo.
Recruitment status was:  Active, not recruiting
First Posted : December 19, 2013
Last Update Posted : December 19, 2013
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Joyce Hisae Yamamoto, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE December 5, 2013
First Posted Date  ICMJE December 19, 2013
Last Update Posted Date December 19, 2013
Study Start Date  ICMJE September 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2013)
  • Visual Acuity change [ Time Frame: 6 months ]
    Visual Acuity will be measured using Snellen charts with best refraction by the same examiner.
  • Change in central foveal thickness [ Time Frame: 6 months ]
    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.
  • Presence or absence of intra/subretinal fluid in OCT [ Time Frame: 6 months ]
    OCT will be analyzed at 6 and 12 months for the presence of intra or subretinal fluid.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2013)
  • Visual Acuity change [ Time Frame: 12 months ]
    Visual Acuity will be measured using Snellen charts with best refraction by the same examiner.
  • Change in Central Foveal Thickness [ Time Frame: 12 months ]
    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.
  • Presence or Absence of Intra/Subretinal fluid in OCT [ Time Frame: 12 months ]
    OCT will be analyzed at 6 and 12 months for the presence of intra or subretinal fluid.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravitreal Bevacizumab for the Treatment of CNV in VKH Disease - A Prospective Study
Official Title  ICMJE Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization in Vogt-Koyanagi-Harada Disease - A Prospective Study
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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Choroidal Neovascularization
Intervention  ICMJE Drug: bevacizumab
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.
Other Name: Bevacizumab (Avastin;Genentech Inc,USA)
Study Arms  ICMJE Experimental: Anti-VEGF and Immunosuppression

Bevacizumab: Dosage 1.25mg/0.05ml; Frequency monthly injections; Duration at least 3 months.

Immunosuppression: cyclosporine and/or azathioprine

Intervention: Drug: bevacizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: December 12, 2013)
9
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2014
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients diagnosed with Vogt-Koyanagi-Harada disease based on Revised Diagnostic Criteria presented by the International Committee on VKH disease in 2001;
  2. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02015351
Other Study ID Numbers  ICMJE Brazilian VKH Study Group
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joyce Hisae Yamamoto, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
Principal Investigator: Joyce H Yamamoto, MD University of Sao Paulo School of Medicine Ophthalmology
Principal Investigator: Viviane M Sakata, MD University of Sao Paulo
PRS Account University of Sao Paulo
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP