Vascular Endothelial Growth Factor (VEGF) & LOC387715/HTRA1 Polymorphism in Polypoidal Choroidal Vasculopathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong Ho Park, Kyungpook National University
ClinicalTrials.gov Identifier:
NCT01233128
First received: November 1, 2010
Last updated: April 6, 2012
Last verified: April 2012
  Purpose

This study is to investigate whether there is an association of the LOC387715/HTRA1 and vascular endothelial growth factor polymorphism with response to treatment with intravitreal ranibizumab injections for patients with polypoidal choroidal vasculopathy.


Condition
Age-Related Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Association of Vascular Endothelial Growth Factor and LOC387715/HTRA1 Polymorphisms With the Response to Intravitreal Ranibizumab Injections in Polypoidal Choroidal Vasculopathy

Resource links provided by NLM:


Further study details as provided by Kyungpook National University:

Primary Outcome Measures:
  • 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 before treatment and BCVA up to 12 months.


Secondary Outcome Measures:
  • Angiographic characteristics [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    Fluorescein angiography (FA) and ICGA (HRA; Heidelberg Engineering, Dossenheim, Germany)were evaluated. Greatest linear dimension (GLD) was determined based on both FA and ICGA.


Biospecimen Retention:   Samples With DNA

Genomic DNA was extracted from peripheral blood with the Qiagen QIAamp Blood Kit (Qiagen, Valencia, CA).


Enrollment: 121
Study Start Date: October 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
polypoidal choroidal vasculopathy
patients who were treated for polypoidal choroidal vasculopathy with intravitreal injections of 0.5 mg of ranibizumab monthly for 3 months

Detailed Description:

This is a retrospective comparative case series comprised of 70 patients being treated for polypoidal choroidal vasculopathy with intravitreal ranibizumab injections and 112 control subjects. Patients were genotyped for the LOC387715 (rs10490924), HTRA1 gene (rs11200638), and VEGF (rs3025039 and rs833069)polymorphism using Real-Time polymerase chain reaction.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • patients older than 60 years of age at onset
  • polyp-like terminal aneurysmal dilations with or without branching vascular networks in ICGA and subretinal reddish-orange protrusions corresponding to polyp-like lesions
  • patients who had intravitreal injections of 0.5 mg of ranibizumab monthly for 3 months

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01233128

Locations
Korea, Republic of
In Taek Kim
Daegu, Kyungsangpookdo, Korea, Republic of, 700-721
Sponsors and Collaborators
Kyungpook National University
Investigators
Principal Investigator: In Taek Kim, M.D. Kyungpook National University
  More Information

Additional Information:
Publications:
Responsible Party: Dong Ho Park, clinical professor, Kyungpook National University
ClinicalTrials.gov Identifier: NCT01233128     History of Changes
Other Study ID Numbers: VEGF & LOC387715/HTRA1
Study First Received: November 1, 2010
Last Updated: April 6, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Macular Degeneration
Vascular Diseases
Retinal Degeneration
Retinal Diseases
Eye Diseases
Cardiovascular Diseases
Mitogens
Endothelial Growth Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014