UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010577 |
|---|---|
| Receipt number | R000012350 |
| Scientific Title | Study of efficacy of aflibercept in neovascular age-related macular degeneration (wAMD) with non-responder of ranibizumab |
| Date of disclosure of the study information | 2013/04/26 |
| Last modified on | 2015/10/24 21:02:31 |
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Basic information
Public title
Study of efficacy of aflibercept in neovascular age-related macular degeneration (wAMD) with non-responder of ranibizumab
Acronym
Study of aflibercept in wAMD with non-responder of ranibizumab
Scientific Title
Study of efficacy of aflibercept in neovascular age-related macular degeneration (wAMD) with non-responder of ranibizumab
Scientific Title:Acronym
Study of aflibercept in wAMD with non-responder of ranibizumab
Region
| Japan |
Condition
Condition
Age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of aflibercept on macula fluid on optical coherence tomography in wAMD patients with non-responder of ranibizumab
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Macula fluid on OCT at month 3
Key secondary outcomes
Change of BCVA, central macular thickness
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
aflibercept
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Willingness to provide written informed consent
2) Subfoveal CNV secondary to AMD on OCT
3) History treatment with ranibizumab for wAMD
4) Decimal BCVA > 0.05
5) The first ranibizumab treatment was within the past 12 months from the first injection of aflibercept
6) Non-responder of ranibizumab (ranibizumab treatments > 4, VA gain at least once with ranibizumab treatment, persistent fluid on OCT after each the last 2 injections of ranibizumab, No VA gain)
Key exclusion criteria
1) Greatest Linear Dimension (GLD) of the total lesion area <12 Macular Photocoagulation Study Disc Areas
2) Prior treatment with photodynamic therapy (PDT) within the past 3 months or more than 4 prior PDT treatment
3) Presence of RPE tears, or subretinal hemorrhage, scar or macular fibrosis (>50% lesion area area)
4) Prior treatment with aflibercept
5) Prior treatment with triamcinolone within 6 months
6) Prior treatment with dexamethasone within 30 days
7) Intraocular surgery within 6 months, vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
8) Active intraocular inflammation
9) Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Ogura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN
TEL
052-053-8251
ogura@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Yasukawa |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN
TEL
052-053-8251
Homepage URL
yasukawa@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2012 | Year | 12 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 24 | Day |
Last modified on
| 2015 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012350
