Unique ID issued by UMIN | UMIN000010171 |
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Receipt number | R000011907 |
Scientific Title | Study of Eylea in patients with wet age-related macular degeneration |
Date of disclosure of the study information | 2013/03/13 |
Last modified on | 2016/03/14 16:59:19 |
Study of Eylea in patients with wet age-related macular degeneration
Study of Eylea in patients with wAMD
Study of Eylea in patients with wet age-related macular degeneration
Study of Eylea in patients with wAMD
Japan |
Age-related macular degeneration
Ophthalmology |
Others
NO
To investigate the efficacy of aflibercept (Eylea) with 3 injections for loading phase and bimonthly injections in patients with wAMD
Efficacy
Proportion of maintained visual acuity at month 12
Change of (best-collected visual acuity) BCVA, central macular thickness, subretinal fluid, fundus autofluorescence and polyps regression
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Eylea (aflibercept)
45 | years-old | <= |
Not applicable |
Male and Female
1) BCVA: 0.1-1.0
2) AMD with Subfoveal fluid on fluorescent angiography, indocyanine green angiography and/or optical coherence tomography
3) Willingness to provide written informed consent
4) outpatient
1) Greatest Linear Dimension (GLD) of the total lesion area <12 Macular Photocoagulation Study Disc Areas
2) Presence of subretinal hemorrhage, scar or macular fibrosis (>50% lesion area)
3) Prior treatment with anti-VEGF drug, photodynamic therapy
4) Prior treatment with dexamethasone (<6 months) or triamcinolone (<30 days), intraocular surgery (<3 months)
5) Active intraocular inflammation
6) Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products
7) Patient who the doctor in charge judges are ineligible for the study
50
1st name | |
Middle name | |
Last name | Aoi Ono |
Kagawa university faculty of medicine
Department of Ophthalmology
1750-1 Ikenobe Miki-cho, Kagawa 761-0793, Japan
+81-87-891-2211
aoiono@med.kagawa-u.ac.jp
1st name | |
Middle name | |
Last name | Aoi Ono |
Kagawa university faculty of medicine
Department of Ophthalmology
1750-1 Ikenobe Miki-cho, Kagawa 761-0793, Japan
+81-87-891-2211
aoiono@med.kagawa-u.ac.jp
Department of Ophthalmology, Kagawa university faculty of medicine
Bayer Yakuhin Ltd.
Profit organization
Japan
NO
2013 | Year | 03 | Month | 13 | Day |
Unpublished
Completed
2013 | Year | 01 | Month | 10 | Day |
2013 | Year | 03 | Month | 06 | Day |
2015 | Year | 02 | Month | 25 | Day |
2015 | Year | 02 | Month | 25 | Day |
2013 | Year | 03 | Month | 05 | Day |
2016 | Year | 03 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011907
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