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

Primary Purpose

Age-Related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LOC387715/HTRA1 genotyping
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Age-Related Macular Degeneration

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • In Taek Kim

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

polypoidal choroidal vasculopathy

control

Arm Description

patients with polypoidal choroidal vasculopathy

control group with no polypoidal choroidal vasculopathy

Outcomes

Primary Outcome Measures

Genotyping of LOC387715/HTRA1 of PCV and control groups
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
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
To evaluate the association between visual acuity and genotype of polypoidal choroidal vasculopathy

Full Information

First Posted
April 19, 2010
Last Updated
August 28, 2011
Sponsor
Kyungpook National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01108250
Brief Title
LOC387715/HTRA1 Variants in Polypoidal Choroidal Vasculopathy in a Korean Population
Acronym
PCV
Official Title
LOC387715/HTRA1 Variants in Polypoidal Choroidal Vasculopathy in a Korean Population
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
polypoidal choroidal vasculopathy
Arm Type
Experimental
Arm Description
patients with polypoidal choroidal vasculopathy
Arm Title
control
Arm Type
Active Comparator
Arm Description
control group with no polypoidal choroidal vasculopathy
Intervention Type
Genetic
Intervention Name(s)
LOC387715/HTRA1 genotyping
Other Intervention Name(s)
genotyping
Intervention Description
Genomic DNA was extracted from whole blood by standard methods. Genotyping was performed using SNP Genotyping Assays.
Primary Outcome Measure Information:
Title
Genotyping of LOC387715/HTRA1 of PCV and control groups
Description
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)
Time Frame
4weeks
Secondary Outcome Measure Information:
Title
Indocyanine angiographic findings of polypoidal choroidal vasculopathy
Description
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.
Time Frame
20 minutes
Title
Visual acuity using Snellen chart
Description
To evaluate the association between visual acuity and genotype of polypoidal choroidal vasculopathy
Time Frame
2 x 5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In Taek Kim, M.D.
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
In Taek Kim
City
Daegu
State/Province
Kyungsangpookdo
ZIP/Postal Code
700-721
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
19268887
Citation
Gotoh N, Nakanishi H, Hayashi H, Yamada R, Otani A, Tsujikawa A, Yamashiro K, Tamura H, Saito M, Saito K, Iida T, Matsuda F, Yoshimura N. ARMS2 (LOC387715) variants in Japanese patients with exudative age-related macular degeneration and polypoidal choroidal vasculopathy. Am J Ophthalmol. 2009 Jun;147(6):1037-41, 1041.e1-2. doi: 10.1016/j.ajo.2008.12.036. Epub 2009 Mar 9.
Results Reference
background
Links:
URL
http://ghr.nlm.nih.gov/
Description
genetics home reference
URL
http://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v:project=medlineplus&query=loc387715
Description
MedlinePlus related topics

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LOC387715/HTRA1 Variants in Polypoidal Choroidal Vasculopathy in a Korean Population

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