Unique ID issued by UMIN | UMIN000011703 |
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Receipt number | R000012529 |
Scientific Title | Randomized controlled phase IV trial of combination aflibercept and Kallidinogenase for neovascular age-related macular degeneration |
Date of disclosure of the study information | 2013/09/10 |
Last modified on | 2014/05/24 16:44:48 |
Randomized controlled phase IV trial of combination aflibercept and Kallidinogenase for neovascular age-related macular degeneration
Combined trial of aflibercept and Kallidinogenase for neovascular age-related macular degeneration
Randomized controlled phase IV trial of combination aflibercept and Kallidinogenase for neovascular age-related macular degeneration
Combined trial of aflibercept and Kallidinogenase for neovascular age-related macular degeneration
Japan |
Age-related macular degeneration
Ophthalmology |
Others
NO
To evaluate whether Kallidinigenase and aflibercept intravitreal injections would provide added efficacy over aflibercept alone.
Safety,Efficacy
central retinal thickness
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Treatment
Medicine |
Kallidinogenase internal use(+) 20cases
Kallidinigenase internal use(-) 20cases
40 | years-old | < |
Not applicable |
Male and Female
Subjects were eligible if the following criteria were met:
1) Intravitreal injection of aflibercept for neovascular age-related macular degeneration
2) Age>40years
3) Ability to provide written informed consent for this study
1)internal use of kallidinogenase
2)intravitreal anti-VEGF therapy or intravitreal steroid therapy in the study eye within the past 6 months
3)photodynamic therapy or focal laser in the study eye within the past 6 months
4)surgical therapy in the study eye within the past 6 months
5)past allergic reaction for kallidinigenase
6)pregnancy (positive pregnancy test) women
7)participation in another simultaneous medical investigation or trial within the past 3 months
8)other conditions that the investigator believed would pose a significant hazard to the subject if investigational therapy were initiated
40
1st name | |
Middle name | |
Last name | Mineo Kondo |
Mie University Graduate School of Medicine
Department of Ophthalmology
2-174 Edobashi Tsu, Mie, Japan
059-232-1111
ganka@clin.medic.mie-u.ac.jp
1st name | |
Middle name | |
Last name | Hisashi Matsubara |
Mie University Graduate School of Medicine
Department of Ophthalmology
2-174 Edobashi Tsu, Mie, Japan
059-232-1111
ganka@clin.medic.mie-u.ac.jp
Mie University Graduate School of Medicine
Department of Ophthalmology
Sanwa Kagaku Kenkyusho Com.,LTD
Profit organization
NO
2013 | Year | 09 | Month | 10 | Day |
Unpublished
Terminated
2013 | Year | 01 | Month | 15 | Day |
2013 | Year | 09 | Month | 11 | Day |
2013 | Year | 09 | Month | 10 | Day |
2014 | Year | 05 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012529
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