Unique ID issued by UMIN | UMIN000016598 |
---|---|
Receipt number | R000019263 |
Scientific Title | Study of visual and anatomical outcomes of second year aflibercept in good visual acuity baseline of wet age-related macular degeneration |
Date of disclosure of the study information | 2015/02/22 |
Last modified on | 2023/06/06 09:45:17 |
Study of visual and anatomical outcomes of second year aflibercept in good visual acuity baseline of wet age-related macular degeneration
Study of second year aflibercept in patients with wAMD
Study of visual and anatomical outcomes of second year aflibercept in good visual acuity baseline of wet age-related macular degeneration
Study of second year aflibercept in patients with wAMD
Japan |
Age-related macular degeneration
Ophthalmology |
Others
NO
To investigate the efficacy of second year aflibercept with monthly treat and extend regimen in patients with good visual acuity wAMD.
Efficacy
Change of best-collected visual acuity and proportion of improved, maintained and deteriorated visual acuity at month 24 from 12 after initial injection of aflibercept
Change of (best-collected visual acuity) BCVA, central macular thickness, subretinal fluid and polyps regression
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) baseline BCVA in the study eye over 0.5 (Decimal VA)
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
5) second year aflibercept treatment
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
42
1st name | |
Middle name | |
Last name | Hidenori Takahashi |
Jichi Medical University
Department of Ophthalmology
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
0285-58-7382
takahah-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Hidenori Takahashi |
Jichi Medical University
Department of Ophthalmology
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
0285-58-7382
takahah-tky@umin.ac.jp
Department of Ophthalmology, Jichi Medical University
Bayer Yakuhin Ltd.
Profit organization
Japan
JCHO Tokyo Shinjuku Medical Center
NO
2015 | Year | 02 | Month | 22 | Day |
https://doi.org/10.2147/OPTH.S160961
Published
https://doi.org/10.2147/OPTH.S160961
39
Intravitreal aflibercept for exudative age-related macular degeneration with good visual acuity: 2-year results of a prospective study.
Shinichi Sakamoto, Hidenori Takahashi, Yuji Inoue, Yusuke Arai, Satoru Inoda, Natsuko Kakinuma, Yujiro Fujino, Tatsuro Tanabe, Hidetoshi Kawashima, Yasuo Yanagi
Clinical ophthalmology (Auckland, N.Z.) 12 1137-1147 2018
2023 | Year | 06 | Month | 06 | Day |
 Japanese Age-related Macular Degeneration
Recruited at each facility for 2 years of regular medical care
None
Visual Acuity and Central Subfield Thickness
Completed
2015 | Year | 01 | Month | 08 | Day |
2015 | Year | 02 | Month | 16 | Day |
2015 | Year | 02 | Month | 22 | Day |
2016 | Year | 08 | Month | 31 | Day |
2017 | Year | 08 | Month | 31 | Day |
2015 | Year | 02 | Month | 22 | Day |
2023 | Year | 06 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019263