This trial is active, not recruiting.

Condition choroidal neovascularization
Treatment bevacizumab
Target VEGF
Sponsor University of Sao Paulo
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date September 2012
End date October 2013
Trial size 9 participants
Trial identifier NCT02015351, Brazilian VKH Study Group


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Bevacizumab: Dosage 1.25mg/0.05ml; Frequency monthly injections; Duration at least 3 months. Immunosuppression: cyclosporine and/or azathioprine
bevacizumab Bevacizumab (Avastin;Genentech Inc,USA)
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.

Primary Outcomes

Visual Acuity change
time frame: 6 months
Change in central foveal thickness
time frame: 6 months
Presence or absence of intra/subretinal fluid in OCT
time frame: 6 months

Secondary Outcomes

Visual Acuity change
time frame: 12 months
Change in Central Foveal Thickness
time frame: 12 months
Presence or Absence of Intra/Subretinal fluid in OCT
time frame: 12 months

Eligibility Criteria

Male or female participants from 10 years up to 70 years old.

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.

Additional Information

Official title Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization in Vogt-Koyanagi-Harada Disease - A Prospective Study
Principal investigator Joyce H Yamamoto, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by University of Sao Paulo.