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

Sponsor
University of Sao Paulo
Study ID
NCT02015351
Status
Completed

Conditions

  • Choroidal Neovascularization

Eligibility Criteria

Sex
ALL
Age
10 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Dec 19, 2013
Start date
Sep 30, 2012
Status verified
Jan 2022
Primary completion
Oct 31, 2017
Completion
Oct 31, 2018

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Visual Acuity change [ Time Frame: 6 months ]

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