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
About this trial
This is an interventional treatment trial for Central Serous Chorioretinopathy
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
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
NCT ID
NCT00864773
First Posted
March 18, 2009
Last Updated
March 18, 2009
Sponsor
Hallym University Medical Center
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
We'll reach out to this number within 24 hrs