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The Effect of Therapy With Bevacizumab in Chronic Central Serous Chorioretinopathy

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ClinicalTrials.gov Identifier: NCT00864773
Recruitment Status : Unknown
Verified March 2009 by Hallym University Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : March 19, 2009
Last Update Posted : March 19, 2009
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment
Central Serous Chorioretinopathy Procedure: intravitreal injection with anterior paracentesis

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Intraocular Concentrations of Growth Factors and Cytokines in Chronic Central Serous Chorioretinopathy And the Effect of Therapy With Bevacizumab
Study Start Date : March 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Procedure: intravitreal injection with anterior paracentesis
    0.1cc Aqueous humor samples were taken each time an intravitreal injection of bevacizumab (2.5 mg in 0.1 ml)
    Other Names:
    • Bevacizumab (Avastin, Genetech)
    • an antibody to vascular endothelial growth factor (VEGF)

Outcome Measures

Primary Outcome Measures :
  1. Concentrations of growth factors and inflammatory cytokines in Aqueous humor [ Time Frame: at baseline ]

Secondary Outcome Measures :
  1. Central macular thickness at optical coherence tomography [ Time Frame: baseline, 1 month, 3 months, 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
More Information

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT00864773     History of Changes
Other Study ID Numbers: 2009-3-16
First Posted: March 19, 2009    Key Record Dates
Last Update Posted: March 19, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Bevacizumab
Endothelial Growth Factors
Mitogens
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action