Unique ID issued by UMIN | UMIN000041389 |
---|---|
Receipt number | R000046988 |
Scientific Title | A 2-year study comparing the efficacy and safety of anti-VEGF drugs (aflibercept and brolucizumab) in patients with exudative age-related macular degeneration. |
Date of disclosure of the study information | 2020/08/12 |
Last modified on | 2020/09/28 22:04:22 |
A 2-year study comparing the efficacy and safety of anti-VEGF drugs (aflibercept and brolucizumab) in patients with exudative age-related macular degeneration.
Efficacy of anti-VEGF drugs (aflibercept and brolucizumab) against wAMD
A 2-year study comparing the efficacy and safety of anti-VEGF drugs (aflibercept and brolucizumab) in patients with exudative age-related macular degeneration.
Efficacy of anti-VEGF drugs (aflibercept and brolucizumab) against wAMD
Japan |
wet age-related macular degeneration
Ophthalmology |
Others
NO
To compare the efficacy and safety of anti-VEGF drugs (aflibercept and brolucizumab) in patients with wet age-related macular degeneration with subfoveal choroidal neovascularization (CNV).
Safety,Efficacy
Amount of change in visual acuity at 52 weeks
The average treatment number according to the medicine , central macular thickness, change of leakage in retinal region, leakage from a polyp, leakage from choroidal neovascularization, subretinal fluid , the rate of incident and the enlargement of the geographic atrophy
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Eylea (aflibercept)
Beovu(brolucizmab)
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
140
1st name | chieko |
Middle name | |
Last name | shiragami |
kagawa university hospital
Ophthalmology
761-0793
1750-1, ikenobe, mikicho, kitagun, kagawa
0878912211
chappi@med.kagawa-u.ac.jp
1st name | yukiko |
Middle name | |
Last name | miyoshi |
kagawa university hospital
Ophthalmology
761-0793
1750-1, ikenobe, mikicho, kidagun, kagawa
0878912211
yukiko-m@med.kagawa-u.ac.jp
kagawa univercity
nothing
Self funding
kagawa university hospital
1750-1, ikenobe, mikicho, kitagun, kagawa
0878912211
yukiko-m@med.kagawa-u.ac.jp
NO
2020 | Year | 08 | Month | 12 | Day |
Unpublished
Preinitiation
2020 | Year | 07 | Month | 20 | Day |
2020 | Year | 07 | Month | 20 | Day |
2024 | Year | 08 | Month | 31 | Day |
2020 | Year | 08 | Month | 11 | Day |
2020 | Year | 09 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046988
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |