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

Age-Related Macular Degeneration Clinical Trial

— PCV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108250
• Other study ID #: LOC387715/HTRA1
• Status: Completed
• Phase: N/A
• First received: April 19, 2010
• Last updated: August 28, 2011
• Start date: April 2010
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: August 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Genetic:
• LOC387715/HTRA1 genotyping
Genomic DNA was extracted from whole blood by standard methods. Genotyping was performed using SNP Genotyping Assays.

Locations

Country	Name	City	State
Korea, Republic of	In Taek Kim	Daegu	Kyungsangpookdo

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	20 minutes	No
Secondary	Visual acuity using Snellen chart	To evaluate the association between visual acuity and genotype of polypoidal choroidal vasculopathy	2 x 5 minutes	No

External Links

•   genetics home reference
•   MedlinePlus related topics