Vascular Endothelial Growth Factor (VEGF) & LOC387715/HTRA1 Polymorphism in Polypoidal Choroidal Vasculopathy
This study has been completed.
Sponsor:
Kyungpook National University
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
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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:
Genetics Home Reference related topics:
age-related macular degeneration
MedlinePlus related topics:
Vascular Diseases
U.S. FDA Resources
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
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 Eye Diseases Retinal Degeneration Retinal Diseases |
Endothelial Growth Factors Growth Substances Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 27, 2015