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

NCT02815176 | Unknown

• 1 other identifier: 2016-02-109
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Serous Chorioretinopathy; Polypoidal Choroidal Vasculopathy

Keywords

Plasminogen activator inhibitor-1; Wide angle fluorescein angiography; Choroid

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Characteristics of fluorescein angiography in active PCV and CSC patients

  Less than 1 week after initial diagnosis

• Characteristics of indocyanine green angiography in active PCV and CSC patients

  Less than 1 week after initial diagnosis

Study Arms (3)

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

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

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

Interventions

Blood sampling OTHER

Sampling the blood including DNA to investigate the thrombotic profile

Central serous chorioretinopathy; Epiretinal membrane; Polypoidal choroidal vasculopathy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

De novo patients with active CSC and PCV.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples including DNA will be retained to perform the genotyping analysis of PAI-1 SNP.

MeSH Terms

Conditions

Central Serous Chorioretinopathy; Polypoidal Choroidal Vasculopathy

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Kunho Bae, MD

  Department of ophthalmology, Samsung medical center, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Se Woong Kang, MD

CONTACT

+82-2-3410-3548; swkang@skku.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 28, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 29, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)