LOC387715/HTRA1 and the Combined Photodynamic Therapy With Intravitreal Bevacizumab in Polypoidal Choroidal Vasculopathy

Age-Related Macular Degeneration Clinical Trial

Official title:

LOC387715/HTRA1 Variants and the Response to Combined Photodynamic Therapy With Intravitreal Bevacizumab in Polypoidal Choroidal Vasculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233115
• Other study ID #: LOC387715/HTRA1 & combined PDT
• Status: Completed
• Phase: N/A
• First received: November 1, 2010
• Last updated: August 28, 2011
• Start date: October 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: Observational

Clinical Trial Summary

This study is to investigate whether there is an association of the LOC387715/HTRA1 variants with response to treatment with combined photodynamic therapy and intravitreal bevacizumab for patients with polypoidal choroidal vasculopathy.

Description:

This is a retrospective cohort study comprised of 70 eyes being treated for polypoidal choroidal vasculopathy with combined photodynamic therapy and intravitreal bevacizumab injections. Patients were genotyped for the LOC387715 (rs10490924) and the HTRA1 gene polymorphism (rs11200638).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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 (ICGA) and subretinal reddish-orange protrusions corresponding to polyp-like lesions

• patients who had combined photodynamic therapy and intravitreal bevacizumab injections, and followed up for more than 12 months after the first treatment

Exclusion Criteria:

• patients with retinal or choroidal diseases including pathologic myopia, angioid streaks, idiopathic choroidal neovascularization (CNV), presumed ocular histoplasmosis, and other secondary CNV

• patients who refused genotypic analyses

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

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)

Sakurada Y, Kubota T, Imasawa M, Mabuchi F, Tanabe N, Iijima H. Association of LOC387715 A69S genotype with visual prognosis after photodynamic therapy for polypoidal choroidal vasculopathy. Retina. 2010 Nov-Dec;30(10):1616-21. doi: 10.1097/IAE.0b013e3181 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best-corrected visual acuity	Best-corrected visual acuity (BCVA) using the Snellen chart was evaluated including BCVA up to 12 months	up to 12 months	No
Secondary	Angiographic characteristics	Fluorescein angiography (FA) and ICGA (HRA; Heidelberg Engineering, Dossenheim, Germany) was evaluated. Greatest linear dimension (GLD) was determined based on both FA and ICGA.	up to 12 months	No

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