Unique ID issued by UMIN | UMIN000010997 |
---|---|
Receipt number | R000012812 |
Scientific Title | Intravitreal aflibercept injection for exudative age-related macular degeneration |
Date of disclosure of the study information | 2013/06/19 |
Last modified on | 2016/01/07 10:34:38 |
Intravitreal aflibercept injection for exudative age-related macular degeneration
Intravitreal aflibercept injection for AMD
Intravitreal aflibercept injection for exudative age-related macular degeneration
Intravitreal aflibercept injection for AMD
Japan |
Age-Related Macular Degeneration
Ophthalmology |
Others
NO
To evaluate the efficacy of aflibercept with three consecutive monthly injections for loading phase and bimonthly injections in AMD eyes.
Efficacy
Proportion of maintained visual acuity at month 12
Change of best-corrected visual acuity (BCVA) and central retinal thickness.
Proportion of subretinal fluid and regression ofpolypoidal lesion.
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:0.1-0.5
2)AMD with subfoveal fluid on fluorescein angiography, indocyanine green angiography, and/or optical coherence tomography
3)Patients with willingness to provide written informed consent
4)Outpatients
1)The greatest linear dimension (GLD)>12 Macular Photocoagulation Study Disc Areas
2)Presence of subretinal hemorrhage, scar or macular fibrosis(>50% lesion area)
3)Prior treatment with anti-VEGF drugs, photodynamic therapy
4)Prior treatment with dexamethasone(within 6 months) or triamcinolone (within 30 days), intraocular surgery(within 3 months
5)Active intraocular inflammation
6)Hypersensitivity or allergy to fluoresceinor or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products
7)Patients who the doctor in charge judges are ineligible for the study
50
1st name | |
Middle name | |
Last name | Tetsuju Sekiryu |
Fukushima Medical University School of Medicine
Ophthalmology
1 Hikarigaoka, Fukushima 960-1295, Japan
024-547-1303
sekiryu@fmu.ac.jp
1st name | |
Middle name | |
Last name | Masaaki Saito |
Fukushima Medical University School of Medicine
Ophthalmology
1 Hikarigaoka Fukushima
024-547-1303
smasaaki@fmu.ac.jp
Department of Ophthalmology, Fukushima Medical University School of Medicine
Bayer Yakuhin Ltd.
Profit organization
Japa
NO
2013 | Year | 06 | Month | 19 | Day |
Unpublished
Preinitiation
2013 | Year | 02 | Month | 06 | Day |
2013 | Year | 06 | Month | 01 | Day |
2013 | Year | 06 | Month | 18 | Day |
2016 | Year | 01 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012812
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |