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

Central Serous Chorioretinopathy Clinical Trial

Official title:

Analysis of Plasminogen Activator Inhibitor-1 Level in Chronic Serous Chorioretinopathy and Polypoidal Choroidal Vasculopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02815176
• Other study ID #: 2016-02-109
• Status: Recruiting
• Phase: N/A
• First received: June 13, 2016
• Last updated: June 28, 2016
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: June 2016
• Source: Samsung Medical Center
• Contact: Se Woong Kang, MD
• Phone: +82-2-3410-3548
• Email: swkang[@]skku.edu
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy
• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Fibrinogen in active PCV and CSC patients	Serum Fibrinogen (mg/dl)	Less than 1 week after initial diagnosis	No
Primary	Serum Factor VIII activity in active PCV and CSC patients	Serum Factor VIII activity (%)	Less than 1 week after initial diagnosis	No
Primary	Serum Plasminogen activity in active PCV and CSC patients	Serum Plasminogen activity (%)	Less than 1 week after initial diagnosis	No
Primary	Serum D-dimer in active PCV and CSC patients	Serum D-dimer (µg/mL(FEU))	Less than 1 week after initial diagnosis	No
Primary	Serum Fibrin degradation product in active PCV and CSC patients	Serum Fibrin degradation product (µg/mL)	Less than 1 week after initial diagnosis	No
Primary	Serum PAI-1 antigen in active PCV and CSC patients	Serum PAI-1 (plasminogen activator inhibitor-1) antigen (ng/mL)	Less than 1 week after initial diagnosis	No
Primary	Serum PAI-1 SNP genotyping in active PCV and CSC patients	Serum PAI-1 SNP(single nucleotide polymorphism) genotyping	Less than 1 week after initial diagnosis	No
Secondary	Characteristics of fluorescein angiography in active PCV and CSC patients	Numbers of leaking points of fluorescein dye in fluorescein angiography	Less than 1 week after initial diagnosis	No
Secondary	Characteristics of indocyanine green angiography in active PCV and CSC patients	Numbers of hyperfluorescent spots in indocyanine green angiography	Less than 1 week after initial diagnosis	No