Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Age-related Macular Degeneration
Verteporfin Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Neovascular Age-related Macular Degeneration
1 other identifier
interventional
45
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 12, 2009
CompletedFirst Posted
Study publicly available on registry
December 15, 2009
CompletedFebruary 26, 2016
February 1, 2016
1.6 years
December 12, 2009
February 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Visual acuity
The comparison between baseline and 12-month
Study Arms (1)
Bevacizumab
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Ophthalmology and Visual Science, Graduate School of Medical Sciences, Kumamoto University
Kumamoto, 860-8556, Japan
Related Publications (1)
Hara R, Kawaji T, Inomata Y, Tahara J, Sagara N, Fukushima M, Tanihara H. Photodynamic therapy alone versus combined with intravitreal bevacizumab for neovascular age-related macular degeneration without polypoidal choroidal vasculopathy in Japanese patients. Graefes Arch Clin Exp Ophthalmol. 2010 Jul;248(7):931-6. doi: 10.1007/s00417-010-1343-8. Epub 2010 Mar 10.
PMID: 20221623DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Takahiro Kawaji, MD, PhD
Department of Ophthalmology, Kumamoto University Graduate School & Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 12, 2009
First Posted
December 15, 2009
Study Start
October 1, 2006
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
February 26, 2016
Record last verified: 2016-02