Trial record 2 of 2 for:    "Vogt-Koyanagi-Harada syndrome"

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Joyce Hisae Yamamoto, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT02015351
First received: December 5, 2013
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Choroidal Neovascularization
Drug: bevacizumab

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 9
Study Start Date: September 2012
Estimated Study Completion Date: June 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anti-VEGF and Immunosuppression

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

Immunosuppression: cyclosporine and/or azathioprine

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)

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.

  Eligibility

Ages Eligible for Study:   10 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02015351

Locations
Brazil
Hospital das Clínicas- University of Sao Paulo
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Joyce H Yamamoto, MD University of Sao Paulo School of Medicine Ophthalmology
Principal Investigator: Viviane M Sakata, MD University of Sao Paulo
  More Information

Publications:

Responsible Party: Joyce Hisae Yamamoto, MD, PhD, Coordinator of the Uveitis Service, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02015351     History of Changes
Other Study ID Numbers: Brazilian VKH Study Group
Study First Received: December 5, 2013
Last Updated: December 12, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Choroidal neovascularization
Vogt Koyanagi Harada Disease
Inflammatory choroidal neovascularization
Anti-VEGF

Additional relevant MeSH terms:
Neovascularization, Pathologic
Uveomeningoencephalitic Syndrome
Choroidal Neovascularization
Metaplasia
Pathologic Processes
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Meningoencephalitis
Central Nervous System Infections
Central Nervous System Diseases
Uveitis
Uveal Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases
Choroid Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014