Unique ID issued by UMIN | UMIN000011273 |
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Receipt number | R000013212 |
Scientific Title | Effect of aflibercept in wet age-related macular degenaration (wAMD) with retinal pigment epithelium detachment (PED) |
Date of disclosure of the study information | 2013/07/25 |
Last modified on | 2018/07/30 08:35:56 |
Effect of aflibercept in wet age-related macular degenaration (wAMD) with retinal pigment epithelium detachment (PED)
Effect of aflibercept in wAMD with PED
Effect of aflibercept in wet age-related macular degenaration (wAMD) with retinal pigment epithelium detachment (PED)
Effect of aflibercept in wAMD with PED
Japan |
exudative age related macular degeneration
Ophthalmology |
Others
NO
To investigate the effect of aflibercept on visual acuity and retinal morphology in AMD with PED
Efficacy
1) Ratio of patients with improved/maintained BCVA at month 12
2) Ratio of patients with PED regression
Change of BCVA, PED, central macular thickness, polyp lesion, etc.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
aflibercept
50 | years-old | <= |
Not applicable |
Male and Female
1) Willingness to provide written informed consent
2) wAMD with CNV on FA, ICGA, OCT
3) PED (>1 disc diameter) on OCT
4) Treatment naïve
5) BCVA > 0.1 (decimal score)
1) Drusenoid PED
2) Avascular PED
3) GLD of the total lesion area > 12
4) Presence of RPE tears or macular hole
5) Subretinal hemorrhage, scar or macular fibrosis (>50% lesion area)
5) History of Triamcinolone (< 6 months), dexamethasone (< 30 days), intraocular surgery (< 6 months)
6) Vitrectomy, submacular surgery, etc.
7) Active intraocular inflammation
8) Hypersensitivity or allergy to fluorescein, indocyanine green, etc.
9) Pregnancy, lactating woman
50
1st name | |
Middle name | |
Last name | Kanji Takahashi |
Kansai Medical University
Department of Ophthalmology
Shinmachi 2-5-1, Hirakata
072-804-0101
nagaiy@hirakata.kmu.ac.jp
1st name | |
Middle name | |
Last name | Yoshimi Nagai |
Kansai Medical University
Department of Ophthalmology
Shinmachi 2-5-1, Hirakata
072-804-0101
nagaiy@hirakata.kmu.ac.jp
Kansai Medical University
Bayer Yakuhin Ltd.
Profit organization
Japan
NO
関西医科大学附属病院、関西医科大学附属滝井病院、大阪大学医学部附属病院、住友病院
2013 | Year | 07 | Month | 25 | Day |
Unpublished
Terminated
2013 | Year | 07 | Month | 11 | Day |
2013 | Year | 08 | Month | 01 | Day |
2015 | Year | 06 | Month | 30 | Day |
2013 | Year | 07 | Month | 25 | Day |
2018 | Year | 07 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013212
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