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

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ClinicalTrials.gov Identifier: NCT01108250
Recruitment Status : Completed
First Posted : April 21, 2010
Last Update Posted : August 30, 2011
Sponsor:
Information provided by (Responsible Party):
Dong Ho Park, Kyungpook National University

Brief Summary:
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 or disease Intervention/treatment Phase
Age-Related Macular Degeneration Genetic: LOC387715/HTRA1 genotyping Not Applicable

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)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: LOC387715/HTRA1 Variants in Polypoidal Choroidal Vasculopathy in a Korean Population
Study Start Date : April 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2011

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U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Genotyping of LOC387715/HTRA1 of PCV and control groups [ Time Frame: 4weeks ]
    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 :
  1. Indocyanine angiographic findings of polypoidal choroidal vasculopathy [ Time Frame: 20 minutes ]
    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.

  2. Visual acuity using Snellen chart [ Time Frame: 2 x 5 minutes ]
    To evaluate the association between visual acuity and genotype of polypoidal choroidal vasculopathy



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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Responsible Party: Dong Ho Park, clinical professor, Kyungpook National University
ClinicalTrials.gov Identifier: NCT01108250     History of Changes
Other Study ID Numbers: LOC387715/HTRA1
First Posted: April 21, 2010    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011

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