Central Serous ChorioretinopathyNCT02815176
Angiographic Characteristics of CSC, PCV Patients and Thrombotic Bio-markers
An observational study of Central Serous Chorioretinopathy and Polypoidal Choroidal Vasculopathy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Thrombotic biomarkers and angiographic characteristics were compared among the de novo patients of central serous chorioretinopathy (CSC), polypoidal choroidal vasculopathy (PCV) and the control. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Central Serous Chorioretinopathy, Polypoidal Choroidal Vasculopathy
- What is being tested?
- Blood sampling
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2016to Jun 2017
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: De novo patients with active CSC and PCV.
Who may be able to join
- CSC
- neurosensory detachment in optical coherence tomography (OCT)
- focal leakage in fluorescein angiography (FAG) and/or late choroidal hyperpermeability in indocyanine green angiography (ICGA)
- PCV
- subretinal and/or sub-retinal pigment epithelial fluid in OCT
- branching vascular network and/or polyps in ICGA
Show all 9Show fewer
- Control
- epiretinal membrane (ERM)
- without underlying systemic, ophthalmic disease other than ERM
Who cannot join
- Previous history of using steroid (oral, topical)
- Previous history of CSC/PCV
- Previous history or evidence of intraocular inflammation including uveitis
- Co-existing retinal or choroidal diseases
- History of allergic reaction to fluorescein or indocyanine green dye
- Underlying systemic conditions that could affect the thrombotic profiles (e.g. diabetes, hypertension, metabolic syndrome, coronary artery disease, cerebrovascular diseases, stroke, chronic renal failure, current smoker, pregnancy, sleep disorder)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Se Woong Kang, MD, +82-2-3410-3548, swkang@skku.edu
Kunho Bae, MD, +82-10-9933-5224, luben81@gmail.com
About this study
Official title: Analysis of Plasminogen Activator Inhibitor-1 Level in Chronic Serous Chorioretinopathy and Polypoidal Choroidal Vasculopathy
Thrombotic biomarkers and angiographic characteristics were compared among the de novo patients of central serous chorioretinopathy (CSC), polypoidal choroidal vasculopathy (PCV) and the control.
- Being tested
- Blood sampling
- Keywords
- Plasminogen activator inhibitor-1, Wide angle fluorescein angiography, Choroid
- Medical subject headings
- Central Serous Chorioretinopathy, Polypoidal Choroidal Vasculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Sampling the blood including DNA to investigate the thrombotic profile
| Study group | Role | What they receive |
|---|---|---|
| Central serous chorioretinopathy | De novo eligible CSC patients will be allocated in this group. Blood sampling, fluorescein angiography, indocyanine green angiography will be performed within a week after initial diagnosis. Receives: Other: Blood sampling | |
| Polypoidal choroidal vasculopathy | De novo eligible PCV patients will be allocated in this group. Blood sampling, fluorescein angiography, indocyanine green angiography will be performed within a week after initial diagnosis. Receives: Other: Blood sampling | |
| Epiretinal membrane | Idiopathic ERM patients will be allocated in this group. Blood sampling, fluorescein angiography, indocyanine green angiography will be performed within a week after initial diagnosis. Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Fibrinogen in active PCV and CSC patients
Serum Fibrinogen (mg/dl)
Measured: Less than 1 week after initial diagnosis
Serum Factor VIII activity in active PCV and CSC patients
Serum Factor VIII activity (%)
Measured: Less than 1 week after initial diagnosis
Serum Plasminogen activity in active PCV and CSC patients
Serum Plasminogen activity (%)
Measured: Less than 1 week after initial diagnosis
Serum D-dimer in active PCV and CSC patients
Serum D-dimer (μg/mL(FEU))
Measured: Less than 1 week after initial diagnosis
Serum Fibrin degradation product in active PCV and CSC patients
Serum Fibrin degradation product (μg/mL)
Measured: Less than 1 week after initial diagnosis
Serum PAI-1 antigen in active PCV and CSC patients
Serum PAI-1 (plasminogen activator inhibitor-1) antigen (ng/mL)
Measured: Less than 1 week after initial diagnosis
Serum PAI-1 SNP genotyping in active PCV and CSC patients
Serum PAI-1 SNP(single nucleotide polymorphism) genotyping
Measured: Less than 1 week after initial diagnosis
Secondary outcomes (2)
Characteristics of fluorescein angiography in active PCV and CSC patients
Numbers of leaking points of fluorescein dye in fluorescein angiography
Measured: Less than 1 week after initial diagnosis
Characteristics of indocyanine green angiography in active PCV and CSC patients
Numbers of hyperfluorescent spots in indocyanine green angiography
Measured: Less than 1 week after initial diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (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.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kunho Bae, MD, Principal investigator, Department of ophthalmology, Samsung medical center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815176
- Sponsor's protocol ID
- 2016-02-109
- Status last verified
- Jun 2016
- First submitted
- 13 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Plasminogen Activator Inhibitor-1 Level in Chronic Serous Chorioretinopathy and Polypoidal Choroidal Vasculopathy
- ClinicalTrials.gov ID
- NCT02815176
- Acronym / sponsor ID
- 2016-02-109
- Keywords
- Plasminogen activator inhibitor-1, Wide angle fluorescein angiography, Choroid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 28 Jun 2016 (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.
Thrombotic biomarkers and angiographic characteristics were compared among the de novo patients of central serous chorioretinopathy (CSC), polypoidal choroidal vasculopathy (PCV) and the control.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Central serous chorioretinopathy | – | Other: Blood samplingDe novo eligible CSC patients will be allocated in this group. Blood sampling, fluorescein angiography, indocyanine green angiography will be performed within a week after initial diagnosis. |
| Polypoidal choroidal vasculopathy | – | Other: Blood samplingDe novo eligible PCV patients will be allocated in this group. Blood sampling, fluorescein angiography, indocyanine green angiography will be performed within a week after initial diagnosis. |
| Epiretinal membrane | – | Other: Blood samplingIdiopathic ERM patients will be allocated in this group. Blood sampling, fluorescein angiography, indocyanine green angiography will be performed within a week after initial diagnosis. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- De novo patients with active CSC and PCV.
Key inclusion criteria (9 listed)
- CSC
- PCV
- Control
Key exclusion criteria (6 listed)
- Previous history of using steroid (oral, topical)
- Previous history of CSC/PCV
- Previous history or evidence of intraocular inflammation including uveitis
- Co-existing retinal or choroidal diseases
- History of allergic reaction to fluorescein or indocyanine green dye
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 |
|---|---|---|
| Blood samplingSampling the blood including DNA to investigate the thrombotic profile | Other | Central serous chorioretinopathy, Epiretinal membrane, Polypoidal choroidal vasculopathy |
Primary outcome
Serum Fibrinogen in active PCV and CSC patients
Time frame: Less than 1 week after initial diagnosis
Serum Fibrinogen (mg/dl)
Serum Factor VIII activity in active PCV and CSC patients
Time frame: Less than 1 week after initial diagnosis
Serum Factor VIII activity (%)
Serum Plasminogen activity in active PCV and CSC patients
Time frame: Less than 1 week after initial diagnosis
Serum Plasminogen activity (%)
Serum D-dimer in active PCV and CSC patients
Time frame: Less than 1 week after initial diagnosis
Serum D-dimer (μg/mL(FEU))
Serum Fibrin degradation product in active PCV and CSC patients
Time frame: Less than 1 week after initial diagnosis
Serum Fibrin degradation product (μg/mL)
Serum PAI-1 antigen in active PCV and CSC patients
Time frame: Less than 1 week after initial diagnosis
Serum PAI-1 (plasminogen activator inhibitor-1) antigen (ng/mL)
Serum PAI-1 SNP genotyping in active PCV and CSC patients
Time frame: Less than 1 week after initial diagnosis
Serum PAI-1 SNP(single nucleotide polymorphism) genotyping
2 secondary outcomes
Characteristics of fluorescein angiography in active PCV and CSC patients
Time frame: Less than 1 week after initial diagnosis
Characteristics of indocyanine green angiography in active PCV and CSC patients
Time frame: Less than 1 week after initial diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Kunho Bae, MD principal investigator
Department of ophthalmology, Samsung medical center, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Serous Chorioretinopathy and Polypoidal Choroidal Vasculopathy, run by Samsung Medical Center at 1 site in South Korea.
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 9 inclusion and 6 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 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Se Woong Kang, MD (+82-2-3410-3548, swkang@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Fibrinogen in active PCV and CSC patients (time frame: Less than 1 week after initial diagnosis). The study lists 7 primary outcomes in all. 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 29 Jun 2016.