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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong Ho Park, Kyungpook National University
ClinicalTrials.gov Identifier:
NCT01233115
First received: November 1, 2010
Last updated: August 28, 2011
Last verified: August 2011

November 1, 2010
August 28, 2011
October 2010
August 2011   (final data collection date for primary outcome measure)
Best-corrected visual acuity [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Best-corrected visual acuity (BCVA) using the Snellen chart was evaluated including BCVA up to 12 months
Same as current
Complete list of historical versions of study NCT01233115 on ClinicalTrials.gov Archive Site
Angiographic characteristics [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Fluorescein angiography (FA) and ICGA (HRA; Heidelberg Engineering, Dossenheim, Germany) was evaluated. Greatest linear dimension (GLD) was determined based on both FA and ICGA.
Same as current
Not Provided
Not Provided
 
LOC387715/HTRA1 and the Combined Photodynamic Therapy With Intravitreal Bevacizumab in Polypoidal Choroidal Vasculopathy
LOC387715/HTRA1 Variants and the Response to Combined Photodynamic Therapy With Intravitreal Bevacizumab in Polypoidal Choroidal Vasculopathy

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.

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).

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Genomic DNA was extracted from peripheral blood. The two SNPs (rs10490924 in the LOC387715 locus and rs11200638 in HTRA1 gene) were analyzed by LC480 Real time PCR (Roche, Basel, Switzerland) at D&P Biotech (Daegu, Korea).

Non-Probability Sample

The authors did a retrospective chart review of 70 patients with PCV who were treated at the Department of Ophthalmology, Kyungpook National University Hospital in Daegu, Korea.

Age-Related Macular Degeneration
Not Provided
polypoidal choroidal vasculopathy
patients who were treated for polypoidal choroidal vasculopathy with combined photodynamic therapy and intravitreal bevacizumab injections
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 Jul 27; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
60 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01233115
LOC387715/HTRA1 & combined PDT
Yes
Dong Ho Park, Kyungpook National University
Kyungpook National University
Not Provided
Principal Investigator: In Taek Kim, M.D. Kyungpook National University
Kyungpook National University
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP