NCT01108250

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 30, 2011

Status Verified

August 1, 2011

Enrollment Period

4 months

First QC Date

April 19, 2010

Last Update Submit

August 28, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    4weeks

Secondary Outcomes (2)

  • Indocyanine angiographic findings of polypoidal choroidal vasculopathy

    20 minutes

  • Visual acuity using Snellen chart

    2 x 5 minutes

Study Arms (2)

polypoidal choroidal vasculopathy

EXPERIMENTAL

patients with polypoidal choroidal vasculopathy

Genetic: LOC387715/HTRA1 genotyping

control

ACTIVE COMPARATOR

control group with no polypoidal choroidal vasculopathy

Genetic: LOC387715/HTRA1 genotyping

Interventions

Genomic DNA was extracted from whole blood by standard methods. Genotyping was performed using SNP Genotyping Assays.

Also known as: genotyping
controlpolypoidal choroidal vasculopathy

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

In Taek Kim

Daegu, Kyungsangpookdo, 700-721, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 19268887BACKGROUND

Related Links

MeSH Terms

Conditions

Macular Degeneration

Interventions

Genotype

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

  • In Taek Kim, M.D.

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 21, 2010

Study Start

April 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2011

Last Updated

August 30, 2011

Record last verified: 2011-08

Locations