Clinical trial NCT02815176: Angiographic Characteristics of CSC, PCV Patients and Thrombotic Bio-markers
Official title: Analysis of Plasminogen Activator Inhibitor-1 Level in Chronic Serous Chorioretinopathy and Polypoidal Choroidal Vasculopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Central Serous Chorioretinopathy
Polypoidal Choroidal Vasculopathy
Keywords: Plasminogen activator inhibitor-1
Wide angle fluorescein angiography
Choroid
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: De novo patients with active CSC and PCV.

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.


Eligibility 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)

Primary outcomes:
measure: Serum Fibrinogen in active PCV and CSC patients
timeFrame: Less than 1 week after initial diagnosis
measure: Serum Factor VIII activity in active PCV and CSC patients
timeFrame: Less than 1 week after initial diagnosis
measure: Serum Plasminogen activity in active PCV and CSC patients
timeFrame: Less than 1 week after initial diagnosis
measure: Serum D-dimer in active PCV and CSC patients
timeFrame: Less than 1 week after initial diagnosis
measure: Serum Fibrin degradation product in active PCV and CSC patients
timeFrame: Less than 1 week after initial diagnosis
measure: Serum PAI-1 antigen in active PCV and CSC patients
timeFrame: Less than 1 week after initial diagnosis
measure: Serum PAI-1 SNP genotyping in active PCV and CSC patients
timeFrame: Less than 1 week after initial diagnosis
Secondary outcomes:
measure: Characteristics of fluorescein angiography in active PCV and CSC patients
timeFrame: Less than 1 week after initial diagnosis
measure: Characteristics of indocyanine green angiography in active PCV and CSC patients
timeFrame: Less than 1 week after initial diagnosis
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Department of ophthalmology, Samsung medical center, Seoul, Korea
name: Kunho Bae, MD
role: PRINCIPAL_INVESTIGATOR
References: