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The Effect of Therapy With Bevacizumab in Chronic Central Serous Chorioretinopathy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Hallym University Medical Center.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00864773
First Posted: March 19, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hallym University Medical Center
  Purpose
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 Intervention
Central Serous Chorioretinopathy Procedure: intravitreal injection with anterior paracentesis

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hallym University Medical Center:

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

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

Estimated Enrollment: 10
Study Start Date: March 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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)
  Eligibility

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT00864773     History of Changes
Other Study ID Numbers: 2009-3-16
First Submitted: March 18, 2009
First Posted: March 19, 2009
Last Update Posted: October 12, 2017
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