Unique ID issued by UMIN | UMIN000012221 |
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Receipt number | R000014278 |
Scientific Title | Treatment with aflibercept for AMD cases with better value in optometry |
Date of disclosure of the study information | 2013/11/06 |
Last modified on | 2015/06/09 17:17:06 |
Treatment with aflibercept for AMD cases with better value in optometry
Treatment with aflibercept for AMD cases with better value in optometry (TAABO study)
Treatment with aflibercept for AMD cases with better value in optometry
Treatment with aflibercept for AMD cases with better value in optometry (TAABO study)
Japan |
age-related macular degeneration
Ophthalmology |
Others
NO
To investigate the efficacy of aflibercept with 3 injections for loading phase and bimonthly injections in patients with wAMD who has rather good visual acuity
Efficacy
Percentage of patients with less exudative changes on optical coherence tomography(OCT) at month 6
Results of visual acuity, OCT, angiography, and QOL research
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
treatment with Eylea
20 | years-old | <= |
100 | years-old | >= |
Male and Female
1)Willingness to provide written informed consent
2)AMD with Subfoveal lesion on fluorescent angiography, indocyanine green angiography and/or optical coherence tomography
3)AMD eyes which had not been treated with PDT and/or anti-VEGF
4)baseline BCVA in the study eye over 0.5
1)Prior treatment with triamcinolone (<3 montsh
2)Prior treatment with dexamethasone <30 days)
3)Prior intraocular surgery (<3 months)
4)Prior vitrectomy
5)Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products
6)Patient with pregnancy or its possibility, and with breast-feeding
7)Patient who the doctor in charge judges are ineligible for the study
30
1st name | |
Middle name | |
Last name | Yoko Ozawa |
Keio University, School of Medicine
Department of Ophthalmology
35 Shinanomachi, Shinjukuku Tokyo 160-8582 Japan
03-3353-1211
ozawa@a5.keio.jp
1st name | |
Middle name | |
Last name | Yoko Ozawa |
Keio University, School of Medicine
Department of Ophthalmology
35 Shinanomachi, Shinjukuku Tokyo 160-8582 Japan
03-3353-1211
ozawa@a5.keio.jp
Keio University, School of Medicine
Bayer Yakuhin Ltd.
Profit organization
NO
2013 | Year | 11 | Month | 06 | Day |
Unpublished
Enrolling by invitation
2013 | Year | 08 | Month | 07 | Day |
2013 | Year | 11 | Month | 07 | Day |
2013 | Year | 11 | Month | 05 | Day |
2015 | Year | 06 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014278
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