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LOC387715/HTRA1 Variants in Polypoidal Choroidal Vasculopathy in a Korean Population (PCV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong Ho Park, Kyungpook National University
ClinicalTrials.gov Identifier:
NCT01108250
First received: April 19, 2010
Last updated: August 28, 2011
Last verified: August 2011
History of Changes
  Purpose

This study is to investigate whether variants in the LOC387715 locus and the HtrA serine peptidase 1 (HTRA1) gene within the 10q26 locus are associated with polypoidal choroidal vasculopathy and whether they are associated with clinical patterns including angiographic phenotype in a Korean population.


Condition Intervention
Age-Related Macular Degeneration
 Genetic: LOC387715/HTRA1 genotyping

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: LOC387715/HTRA1 Variants in Polypoidal Choroidal Vasculopathy in a Korean Population

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyungpook National University:

Primary Outcome Measures:
  • Genotyping of LOC387715/HTRA1 of PCV and control groups [ Time Frame: 4weeks ] [ Designated as safety issue: No ]
    to investigate whether variants in the LOC387715 locus and the HtrA serine peptidase 1 (HTRA1) gene within the 10q26 locus are associated with polypoidal choroidal vasculopathy (PCV)


Secondary Outcome Measures:
  • Indocyanine angiographic findings of polypoidal choroidal vasculopathy [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    The association of the risk allele of the LOC387715/HTRA1 and indocyanine angiographic characteristics of polypoidal choroidal vasculopathy including subretinal hemorrhage, pigment epithelial detachment, and serous retinal detachment.

  • Visual acuity using Snellen chart [ Time Frame: 2 x 5 minutes ] [ Designated as safety issue: No ]
    To evaluate the association between visual acuity and genotype of polypoidal choroidal vasculopathy


Enrollment: 215
Study Start Date: April 2010
Study Completion Date: August 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: polypoidal choroidal vasculopathy
patients with polypoidal choroidal vasculopathy
 Genetic: LOC387715/HTRA1 genotyping
Genomic DNA was extracted from whole blood by standard methods. Genotyping was performed using SNP Genotyping Assays.
Other Name: genotyping
Active Comparator: control
control group with no polypoidal choroidal vasculopathy
 Genetic: LOC387715/HTRA1 genotyping
Genomic DNA was extracted from whole blood by standard methods. Genotyping was performed using SNP Genotyping Assays.
Other Name: genotyping

Detailed Description:

This is a cross-sectional case-control study. One hundred Korean patients with polypoidal choroidal vasculopathy and 100 control subjects were genotyped for the LOC387715 (rs10490924) and the HTRA1 gene polymorphism (rs11200638)

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Polypoidal choroidal vasculopathy group

Inclusion Criteria:

  • patients older than 60 years of age at onset
  • polyp-like terminal aneurysmal dilations with or without branching vascular networks in indocyanine green angiography and subretinal reddish-orange protrusions corresponding to polyp-like lesions

Exclusion Criteria:

  • eyes with pathologic myopia, angioid streaks, central serous chorioretinopathy, and other retinal or choroidal diseases

Control group

Inclusion Criteria:

  • individuals without retinal diseases and without any signs of polypoidal choroidal vasculopathy or age-related macular degeneration on the bases of comprehensive ophthalmic examination results
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108250

Locations
Korea, Republic of
In Taek Kim
Daegu, Kyungsangpookdo, Korea, Republic of, 700-721
Sponsors and Collaborators
Kyungpook National University
Investigators
Principal Investigator: In Taek Kim, M.D. Kyungpook National University
  More Information

Additional Information:
genetics home reference  This link exits the ClinicalTrials.gov site
MedlinePlus related topics  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Dong Ho Park, clinical professor, Kyungpook National University
ClinicalTrials.gov Identifier: NCT01108250     History of Changes
Other Study ID Numbers: LOC387715/HTRA1
Study First Received: April 19, 2010
Last Updated: August 28, 2011
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013