Unique ID issued by UMIN | UMIN000012126 |
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Receipt number | R000014181 |
Scientific Title | Study of intravitreal aflibercept for exudative age-related macular degeneration |
Date of disclosure of the study information | 2013/10/25 |
Last modified on | 2016/04/25 13:33:53 |
Study of intravitreal aflibercept for exudative age-related macular degeneration
Intravitreal aflibercept for AMD
Study of intravitreal aflibercept for exudative age-related macular degeneration
Intravitreal aflibercept for AMD
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
Efficacy
Proportion of maintained visual acuity at month 12 (defined as loss of less than 3 lines)
Change of (best-collected visual acuity) BCVA, central macular thickness, subretinal fluid, contrast sensitivity and mean deviation of humphrey visual field
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Eylea (aflibercept)
50 | 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
30
1st name | |
Middle name | |
Last name | Tsutomu Sakai |
Jikei University School of Medicine
Department of Ophthalmology
3-25-8 nishishinbashi minatoku tokyo 105-8461 japan
+81-3-3433-1111
tstmski@jikei.ac.jp
1st name | |
Middle name | |
Last name | Tsutomu Sakai |
Jikei University School of Medicine
Department of Ophthalmology
3-25-8 nishishinbashi minatoku tokyo 105-8461 japan
+81-3-3433-1111
tstmski@jikei.ac.jp
Department of Ophthalmology, Jikei University School of Medicine
Bayer Yakuhin Ltd.
Profit organization
Japan
NO
2013 | Year | 10 | Month | 25 | Day |
Unpublished
No longer recruiting
2013 | Year | 07 | Month | 08 | Day |
2013 | Year | 10 | Month | 25 | Day |
2015 | Year | 10 | Month | 24 | Day |
2013 | Year | 10 | Month | 25 | Day |
2016 | Year | 04 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014181
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