- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01108250
LOC387715/HTRA1 Variants in Polypoidal Choroidal Vasculopathy in a Korean Population (PCV)
August 28, 2011 updated by: Dong Ho Park, Kyungpook National University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
215
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kyungsangpookdo
-
Daegu, Kyungsangpookdo, Korea, Republic of, 700-721
- In Taek Kim
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: polypoidal choroidal vasculopathy
patients with polypoidal choroidal vasculopathy
|
Genomic DNA was extracted from whole blood by standard methods.
Genotyping was performed using SNP Genotyping Assays.
Other Names:
|
Active Comparator: control
control group with no polypoidal choroidal vasculopathy
|
Genomic DNA was extracted from whole blood by standard methods.
Genotyping was performed using SNP Genotyping Assays.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
4weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
20 minutes
|
Visual acuity using Snellen chart
Time Frame: 2 x 5 minutes
|
To evaluate the association between visual acuity and genotype of polypoidal choroidal vasculopathy
|
2 x 5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: In Taek Kim, M.D., Kyungpook National University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
April 19, 2010
First Submitted That Met QC Criteria
April 20, 2010
First Posted (Estimate)
April 21, 2010
Study Record Updates
Last Update Posted (Estimate)
August 30, 2011
Last Update Submitted That Met QC Criteria
August 28, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LOC387715/HTRA1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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