- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01233115
LOC387715/HTRA1 and the Combined Photodynamic Therapy With Intravitreal Bevacizumab in Polypoidal Choroidal Vasculopathy
August 28, 2011 updated by: Dong Ho Park, Kyungpook National University Hospital
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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).
Study Type
Observational
Enrollment (Actual)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Kyungsangpookdo
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Daegu, Kyungsangpookdo, Korea, Republic of, 700-721
- In Taek Kim
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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polypoidal choroidal vasculopathy
patients who were treated for polypoidal choroidal vasculopathy with combined photodynamic therapy and intravitreal bevacizumab injections
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best-corrected visual acuity
Time Frame: up to 12 months
|
Best-corrected visual acuity (BCVA) using the Snellen chart was evaluated including BCVA up to 12 months
|
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Angiographic characteristics
Time Frame: up to 12 months
|
Fluorescein angiography (FA) and ICGA (HRA; Heidelberg Engineering, Dossenheim, Germany) was evaluated.
Greatest linear dimension (GLD) was determined based on both FA and ICGA.
|
up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: In Taek Kim, M.D., Kyungpook National University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
November 1, 2010
First Submitted That Met QC Criteria
November 2, 2010
First Posted (Estimate)
November 3, 2010
Study Record Updates
Last Update Posted (Estimate)
August 30, 2011
Last Update Submitted That Met QC Criteria
August 28, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LOC387715/HTRA1 & combined PDT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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