Central Serous ChorioretinopathyNCT00864773
The Effect of Therapy With Bevacizumab in Chronic Central Serous Chorioretinopathy
A study testing intravitreal injection with anterior paracentesis in people with Central Serous Chorioretinopathy, run by Hallym University Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- intravitreal injection with anterior paracentesis
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Known side effects of systemic bevacizumab administration
- Have a significant cardiovascular or thromboembolic history or were pregnant
About this study
Official title: Intraocular Concentrations of Growth Factors and Cytokines in Chronic Central Serous Chorioretinopathy And the Effect of Therapy With Bevacizumab
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
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- intravitreal injection with anterior paracentesis
- Medical subject headings
- Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal injection with anterior paracentesisProcedure or surgery
Also called Bevacizumab (Avastin, Genetech), an antibody to vascular endothelial growth factor (VEGF)
0.1cc Aqueous humor samples were taken each time an intravitreal injection of bevacizumab (2.5 mg in 0.1 ml)
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of growth factors and inflammatory cytokines in Aqueous humor
Measured: at baseline
Secondary outcomes (1)
Central macular thickness at optical coherence tomography
Measured: baseline, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864773
- Sponsor's protocol ID
- 2009-3-16
- Status last verified
- Mar 2009
- First submitted
- 18 Mar 2009
- Last updated
- 19 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Concentrations of Growth Factors and Cytokines in Chronic Central Serous Chorioretinopathy And the Effect of Therapy With Bevacizumab
- ClinicalTrials.gov ID
- NCT00864773
- Acronym / sponsor ID
- 2009-3-16
- Conditions
- Central Serous Chorioretinopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Known side effects of systemic bevacizumab administration
- Have a significant cardiovascular or thromboembolic history or were pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravitreal injection with anterior paracentesisAlso: Bevacizumab (Avastin, Genetech), an antibody to vascular endothelial growth factor (VEGF)0.1cc Aqueous humor samples were taken each time an intravitreal injection of bevacizumab (2.5 mg in 0.1 ml) | Procedure or surgery | – |
Primary outcome
Concentrations of growth factors and inflammatory cytokines in Aqueous humor
Time frame: at baseline
1 secondary outcome
Central macular thickness at optical coherence tomography
Time frame: baseline, 1 month, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing intravitreal injection with anterior paracentesis in people with Central Serous Chorioretinopathy, run by Hallym University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations of growth factors and inflammatory cytokines in Aqueous humor (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2009.