Intravitreal Bevacizumab for the Treatment of CNV in VKH 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization in Vogt-Koyanagi-Harada Disease - A Prospective Study|
- Visual Acuity change [ Time Frame: 6 months ] [ Designated as safety issue: No ]Visual Acuity will be measured using Snellen charts with best refraction by the same examiner.
- Change in central foveal thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]OCT will be analyzed at 6 and 12 months for the presence of intra or subretinal fluid.
- Visual Acuity change [ Time Frame: 12 months ] [ Designated as safety issue: No ]Visual Acuity will be measured using Snellen charts with best refraction by the same examiner.
- Change in Central Foveal Thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]OCT will be analyzed at 6 and 12 months for the presence of intra or subretinal fluid.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||June 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: 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.
Other Name: Bevacizumab (Avastin;Genentech Inc,USA)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02015351
|Hospital das Clínicas- University of Sao Paulo|
|Sao Paulo, Brazil|
|Principal Investigator:||Joyce H Yamamoto, MD||University of Sao Paulo School of Medicine Ophthalmology|
|Principal Investigator:||Viviane M Sakata, MD||University of Sao Paulo|