We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01233128
First Posted: November 3, 2010
Last Update Posted: April 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dong Ho Park, Kyungpook National University
  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 Dong Ho Park, Kyungpook National University:

Primary Outcome Measures:
  • 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:
  • 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).

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
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
Information from the National Library of Medicine

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
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
First Submitted: November 1, 2010
First Posted: November 3, 2010
Last Update Posted: April 9, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Macular Degeneration
Vascular Diseases
Retinal Degeneration
Retinal Diseases
Eye Diseases
Cardiovascular Diseases
Ranibizumab
Endothelial Growth Factors
Mitogens
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action