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

• Conditions: Polypoidal Choroidal Vasculopathy; Central Serous Chorioretinopathy
• Interventions: Other: Blood sampling

• Registration Number: NCT02815176
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-28
• Last Update Submitted: 2016-06-28
• Last Update Posted: 2016-06-29
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Central serous chorioretinopathy	Blood sampling	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.
Epiretinal membrane	Blood sampling	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.
Polypoidal choroidal vasculopathy	Blood sampling	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.

Primary Outcome Measures

Name	Time	Method
Serum Fibrinogen in active PCV and CSC patients	Less than 1 week after initial diagnosis	Serum Fibrinogen (mg/dl)
Serum PAI-1 SNP genotyping in active PCV and CSC patients	Less than 1 week after initial diagnosis	Serum PAI-1 SNP(single nucleotide polymorphism) genotyping
Serum Factor VIII activity in active PCV and CSC patients	Less than 1 week after initial diagnosis	Serum Factor VIII activity (%)
Serum Plasminogen activity in active PCV and CSC patients	Less than 1 week after initial diagnosis	Serum Plasminogen activity (%)
Serum D-dimer in active PCV and CSC patients	Less than 1 week after initial diagnosis	Serum D-dimer (μg/mL(FEU))
Serum Fibrin degradation product in active PCV and CSC patients	Less than 1 week after initial diagnosis	Serum Fibrin degradation product (μg/mL)
Serum PAI-1 antigen in active PCV and CSC patients	Less than 1 week after initial diagnosis	Serum PAI-1 (plasminogen activator inhibitor-1) antigen (ng/mL)

Secondary Outcome Measures

Name	Time	Method
Characteristics of indocyanine green angiography in active PCV and CSC patients	Less than 1 week after initial diagnosis	Numbers of hyperfluorescent spots in indocyanine green angiography
Characteristics of fluorescein angiography in active PCV and CSC patients	Less than 1 week after initial diagnosis	Numbers of leaking points of fluorescein dye in fluorescein angiography

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of