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Angiographic Characteristics of CSC, PCV Patients and Thrombotic Bio-markers

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ClinicalTrials.gov Identifier: NCT02815176
Recruitment Status : Unknown
Verified June 2016 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : June 28, 2016
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Brief 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.

Condition or disease Intervention/treatment
Central Serous Chorioretinopathy Polypoidal Choroidal Vasculopathy Other: Blood sampling

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Analysis of Plasminogen Activator Inhibitor-1 Level in Chronic Serous Chorioretinopathy and Polypoidal Choroidal Vasculopathy
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: Blood sampling
Sampling the blood including DNA to investigate the thrombotic profile

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.
Other: Blood sampling
Sampling the blood including DNA to investigate the thrombotic profile

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.
Other: Blood sampling
Sampling the blood including DNA to investigate the thrombotic profile




Primary Outcome Measures :
  1. Serum Fibrinogen in active PCV and CSC patients [ Time Frame: Less than 1 week after initial diagnosis ]
    Serum Fibrinogen (mg/dl)

  2. Serum Factor VIII activity in active PCV and CSC patients [ Time Frame: Less than 1 week after initial diagnosis ]
    Serum Factor VIII activity (%)

  3. Serum Plasminogen activity in active PCV and CSC patients [ Time Frame: Less than 1 week after initial diagnosis ]
    Serum Plasminogen activity (%)

  4. Serum D-dimer in active PCV and CSC patients [ Time Frame: Less than 1 week after initial diagnosis ]
    Serum D-dimer (μg/mL(FEU))

  5. 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)

  6. 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)

  7. 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


Secondary Outcome Measures :
  1. Characteristics of fluorescein angiography in active PCV and CSC patients [ Time Frame: Less than 1 week after initial diagnosis ]
    Numbers of leaking points of fluorescein dye in fluorescein angiography

  2. Characteristics of indocyanine green angiography in active PCV and CSC patients [ Time Frame: Less than 1 week after initial diagnosis ]
    Numbers of hyperfluorescent spots in indocyanine green angiography


Biospecimen Retention:   Samples With DNA
Blood samples including DNA will be retained to perform the genotyping analysis of PAI-1 SNP.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
De novo patients with active CSC and PCV.
Criteria

Inclusion Criteria:

  • 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
  • Control

    • epiretinal membrane (ERM)
    • without underlying systemic, ophthalmic disease other than ERM

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815176


Contacts
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Contact: Se Woong Kang, MD +82-2-3410-3548 swkang@skku.edu

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Se Woong Kang, MD    +82-2-3410-3548    swkang@skku.edu   
Contact: Kunho Bae, MD    +82-10-9933-5224    luben81@gmail.com   
Principal Investigator: Se Woong Kang, MD         
Sub-Investigator: Kunho Bae, MD         
Sub-Investigator: Jong Min Kim, MD         
Sub-Investigator: Kyuyeon Cho, MD         
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Kunho Bae, MD Department of ophthalmology, Samsung medical center, Seoul, Korea
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02815176    
Other Study ID Numbers: 2016-02-109
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Samsung Medical Center:
Plasminogen activator inhibitor-1
Wide angle fluorescein angiography
Choroid
Additional relevant MeSH terms:
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Central Serous Chorioretinopathy
Vascular Diseases
Cardiovascular Diseases
Retinal Diseases
Eye Diseases