- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01032109
Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Age-related Macular Degeneration
February 25, 2016 updated by: Takahiro Kawaji, Kumamoto University
Verteporfin Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Neovascular Age-related Macular Degeneration
The purpose of this study is to compare 12-month results of two single initial treatments-photodynamic therapy with verteporfin alone and this therapy combined with intravitreal bevacizumab-for neovascular age-related macular degeneration, not including patients with polypoidal choroidal vasculopathy who were presumed to have age-related macular degeneration.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
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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Kumamoto, Japan, 860-8556
- Department of Ophthalmology and Visual Science, Graduate School of Medical Sciences, Kumamoto University
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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
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- choroidal neovascularization caused by age-related macula degeneration
- no previous treatment
- a follow-up at least 12 months
- a baseline visual acuity ranging from a letter score of 0 to 70 on the Early Treatment Diabetic Retinopathy Study chart
Exclusion Criteria:
- choroidal neovascularization caused by other eye diseases
- ocular surgery within the past 3 mouths
- history of uveitis
- intraocular pressure higher than 25 mmHg, or glaucoma
- history of systemic or ocular thromboembolic events.
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Bevacizumab
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A single intravitreal injection of 1.25 mg of bevacizumab (0.05 mL of solution prepared from Avastin, 100 mg/4 mL vial) was performed within 2 weeks after PDT treatment.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual acuity
Time Frame: The comparison between baseline and 12-month
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The comparison between baseline and 12-month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Takahiro Kawaji, MD, PhD, Department of Ophthalmology, Kumamoto University Graduate School & Medical Sciences
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.
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, 2006
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
December 12, 2009
First Submitted That Met QC Criteria
December 14, 2009
First Posted (Estimate)
December 15, 2009
Study Record Updates
Last Update Posted (Estimate)
February 26, 2016
Last Update Submitted That Met QC Criteria
February 25, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCBK610
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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