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The Effect of Therapy With Bevacizumab in Chronic Central Serous Chorioretinopathy

Primary Purpose

Central Serous Chorioretinopathy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intravitreal injection with anterior paracentesis
Sponsored by
Hallym University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Serous Chorioretinopathy

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a diagnosis of central serous chorioretinopathy
  • Idiopathic neurosensory retinal elevation demonstrated by optical coherent tomography
  • Presence of focal leaks at the level of the RPE on fluorescein angiography

Exclusion Criteria:

  • Known side effects of systemic bevacizumab administration
  • Have a significant cardiovascular or thromboembolic history or were pregnant

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Concentrations of growth factors and inflammatory cytokines in Aqueous humor

    Secondary Outcome Measures

    Central macular thickness at optical coherence tomography

    Full Information

    First Posted
    March 18, 2009
    Last Updated
    March 18, 2009
    Sponsor
    Hallym University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00864773
    Brief Title
    The Effect of Therapy With Bevacizumab in Chronic Central Serous Chorioretinopathy
    Official Title
    Intraocular Concentrations of Growth Factors and Cytokines in Chronic Central Serous Chorioretinopathy And the Effect of Therapy With Bevacizumab
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    March 2010 (Anticipated)
    Study Completion Date
    March 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hallym University Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The pathophysiology of central serous chorioretinopathy remains controversial. traditional treatment is laser photocoagulation or photodynamic therapy.Recently Bevacizumab (Avastin, Genetech),an antibody to vascular endothelial growth factor (VEGF),has known antipermeability properties and therefore may theoretically reverse the changes seen in central serous chorioretinopathy. The aim of this study is To investigate concentrations of growth factors and inflammatory cytokines and to report the effect of therapy with bevacizumab in eyes with central serous chorioretinopathy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Central Serous Chorioretinopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    intravitreal injection with anterior paracentesis
    Other Intervention Name(s)
    Bevacizumab (Avastin, Genetech), an antibody to vascular endothelial growth factor (VEGF)
    Intervention Description
    0.1cc Aqueous humor samples were taken each time an intravitreal injection of bevacizumab (2.5 mg in 0.1 ml)
    Primary Outcome Measure Information:
    Title
    Concentrations of growth factors and inflammatory cytokines in Aqueous humor
    Time Frame
    at baseline
    Secondary Outcome Measure Information:
    Title
    Central macular thickness at optical coherence tomography
    Time Frame
    baseline, 1 month, 3 months, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with a diagnosis of central serous chorioretinopathy Idiopathic neurosensory retinal elevation demonstrated by optical coherent tomography Presence of focal leaks at the level of the RPE on fluorescein angiography Exclusion Criteria: Known side effects of systemic bevacizumab administration Have a significant cardiovascular or thromboembolic history or were pregnant

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Therapy With Bevacizumab in Chronic Central Serous Chorioretinopathy

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