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

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ClinicalTrials.gov Identifier: NCT01233128
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : April 9, 2012
Sponsor:
Information provided by (Responsible Party):
Dong Ho Park, Kyungpook National University Hospital

Study Description
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Brief Summary:
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 or disease
Age-Related Macular Degeneration

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.
Study Design
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Study Type : Observational
Actual Enrollment : 121 participants
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
Study Start Date : October 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

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Groups and Cohorts
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Group/Cohort
polypoidal choroidal vasculopathy
patients who were treated for polypoidal choroidal vasculopathy with intravitreal injections of 0.5 mg of ranibizumab monthly for 3 months


Outcome Measures
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Primary Outcome Measures :
  1. Best-corrected visual acuity [ Time Frame: up to 12 months ]
    Best-corrected visual acuity (BCVA) using the Snellen chart was evaluated including BCVA before treatment and BCVA up to 12 months.


Secondary Outcome Measures :
  1. Angiographic characteristics [ Time Frame: up to 12 months ]
    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).

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233128


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

Publications:

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Responsible Party: Dong Ho Park, clinical professor, Kyungpook National University Hospital
ClinicalTrials.gov Identifier: NCT01233128    
Other Study ID Numbers: VEGF & LOC387715/HTRA1
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: April 9, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases