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

Not Applicable

Completed

• Conditions: Choroidal Neovascularization
• Interventions: Drug: bevacizumab

• Registration Number: NCT02015351
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-19
• Primary Completion: 2017-10
• Study Completion: 2018-10
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anti-VEGF and Immunosuppression	bevacizumab	Bevacizumab: Dosage 1.25mg/0.05ml; Frequency monthly injections; Duration at least 3 months. Immunosuppression: cyclosporine and/or azathioprine

Primary Outcome Measures

Name	Time	Method
Visual Acuity change	6 months	Visual Acuity will be measured using Snellen charts with best refraction by the same examiner.
Change in central foveal thickness	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	6 months	OCT will be analyzed at 6 and 12 months for the presence of intra or subretinal fluid.

Secondary Outcome Measures

Name	Time	Method
Visual Acuity change	12 months	Visual Acuity will be measured using Snellen charts with best refraction by the same examiner.
Change in Central Foveal Thickness	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	12 months	OCT will be analyzed at 6 and 12 months for the presence of intra or subretinal fluid.

Trial Locations

Locations (1)

Hospital das Clínicas- University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil