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

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.

Study Overview

• Status: Unknown
• Conditions: Polypoidal Choroidal Vasculopathy; Central Serous Chorioretinopathy
• Intervention / Treatment: Other: Blood sampling

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Se Woong Kang, MD; Phone Number: +82-2-3410-3548; Email: swkang@skku.edu

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
    • Contact: Se Woong Kang, MD; Phone Number: +82-2-3410-3548; Email: swkang@skku.edu
    • Contact: Kunho Bae, MD; Phone Number: +82-10-9933-5224; Email: luben81@gmail.com
    • Sub-Investigator: Kunho Bae, MD
    • Sub-Investigator: Jong Min Kim, MD
    • Sub-Investigator: Kyuyeon Cho, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

De novo patients with active CSC and PCV.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Fibrinogen in active PCV and CSC patients	Serum Fibrinogen (mg/dl)	Less than 1 week after initial diagnosis
Serum Factor VIII activity in active PCV and CSC patients	Serum Factor VIII activity (%)	Less than 1 week after initial diagnosis
Serum Plasminogen activity in active PCV and CSC patients	Serum Plasminogen activity (%)	Less than 1 week after initial diagnosis
Serum D-dimer in active PCV and CSC patients	Serum D-dimer (μg/mL(FEU))	Less than 1 week after initial diagnosis
Serum Fibrin degradation product in active PCV and CSC patients	Serum Fibrin degradation product (μg/mL)	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)	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	Less than 1 week after initial diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Kunho Bae, MD, Department of ophthalmology, Samsung medical center, Seoul, Korea

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ANTICIPATED): June 1, 2017
• Study Completion (ANTICIPATED): June 1, 2017

Study Registration Dates

• First Submitted: June 13, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (ESTIMATE): June 28, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 29, 2016
• Last Update Submitted That Met QC Criteria: June 28, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Choroid; Plasminogen activator inhibitor-1; Wide angle fluorescein angiography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Eye Diseases; Retinal Diseases; Vascular Diseases; Central Serous Chorioretinopathy
• Other Study ID Numbers: 2016-02-109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO