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The Effect of Therapy With Bevacizumab in Chronic Central Serous Chorioretinopathy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Hallym University Medical Center
ClinicalTrials.gov Identifier:
NCT00864773
First received: March 18, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

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

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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT00864773     History of Changes
Other Study ID Numbers: 2009-3-16
Study First Received: March 18, 2009
Last Updated: March 18, 2009
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013