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

NCT02015351 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-01-05

No results posted yet for this study

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.

Conditions

  • Choroidal Neovascularization

Interventions

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.

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Joyce H Yamamoto, MD · University of Sao Paulo School of Medicine Ophthalmology

  • Viviane M Sakata, MD · University of Sao Paulo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2017-10-31
Completion
2018-10-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02015351 on ClinicalTrials.gov