Intravitreal Bevacizumab for the Treatment of CNV in VKH Disease - A Prospective Study
Condition: Choroidal Neovascularization
MeSH terms: Choroidal Neovascularization; Neovascularization, Pathologic
Study type: Interventional

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.
    

Intervention name(s): bevacizumab
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Bevacizumab (Avastin;Genentech Inc,USA)
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Choroidal neovascularization; Vogt Koyanagi Harada Disease; Inflammatory choroidal neovascularization; Anti-VEGF