Unique ID issued by UMIN | UMIN000012493 |
---|---|
Receipt number | R000014625 |
Scientific Title | Investigation of clinical efficacy of aflicbercept in patients with polypoidal choroidal vasculopathy (PCV) with resistance of ranibizumab |
Date of disclosure of the study information | 2013/12/04 |
Last modified on | 2016/12/02 14:45:40 |
Investigation of clinical efficacy of aflicbercept in patients with polypoidal choroidal vasculopathy (PCV) with resistance of ranibizumab
Investigation of aflivercept for PCV with resistance of ranibizumab
Investigation of clinical efficacy of aflicbercept in patients with polypoidal choroidal vasculopathy (PCV) with resistance of ranibizumab
Investigation of aflivercept for PCV with resistance of ranibizumab
Japan |
Polypoidal choroidal vasculopathy
Ophthalmology |
Others
NO
To investigate the 52-week efficacy of aflibercept on best-collected visual acuity and polypoidal lesions in patients with ranibizumab-resistant PCV by treat-and-adjusted interval injections of aflibercept.
Safety,Efficacy
Exploratory
Proportion of improved/maintained visual acuity at week 52
Regression of polyp on indocyanine green angiography (ICGA)
Change of BCVA (best-collected visual acuity), central macular thickness and subretinal fluid on OCT (optical coherence tomography), disease area on fluorescent angiography, regression of polyp on indocyanine green angiography (ICGA)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
As a loading dose, the patient receives three intravitreal aflibercept injections every 4 weeks.
In the maintenance phase, the patient receives aflibercept injection at every 4-, 6- or 8- week interval.
Patients receive the last injection until 50 weeks.
The number of injections and the timing of the last injection varies among patients. (min # of injections: 8, max # of injections: 13, patients will receive the last injection either on the 44th , 48th, or 50th weeks)
50 | years-old | <= |
Not applicable |
Male and Female
1) Written informed consent
2) age above 50
3) Subfoveal CNV secondary to AMD on FA,IA,OCT
4) PCV on fundus photography and ICGA
5) ranibizumab-resistant Polypoidal choroidal vasculopathy (PCV)
6) BCVA>0.1
7) Treatment-naïve PCV
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 dexamethasone (<6 months) or triamcinolone (<30 days), intraocular surgery (<6 months)
4) Active intraocular inflammation
5) Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products
6) pregnant women and nursing mothers
7) Patient who the doctor in charge judges are ineligible for the study
8) RPE tear or stage3 full-thickness macular hole in the studied eye.
9) Intraocular surgery (including cataract surgery, vitrectomy and subretinal surgery) in the studied eye within 6months.
30
1st name | |
Middle name | |
Last name | Yasuo Yanagi, MD, PhD |
Graduate School of Medicine,
The University of Tokyo
Department of Ophthalmology
7-3-1 Hongo, Bunkyo-Ku, Tokyo
03-3815-5411
yanagi-tky@umin.org
1st name | |
Middle name | |
Last name | Yasuo Yanagi, MD, PhD |
Graduate School of Medicine, The University of Tokyo
Department of Ophthalmology
7-3-1 Hongo, Bunkyo-Ku, Tokyo
03-3815-5411
yanagi-tky@umin.org
Department of Ophthalmology, Graduate School of Medicine,
The University of Tokyo
Bayer Yakuhin Ltd.
Profit organization
NO
東京大学医学部付属病院(東京都)
2013 | Year | 12 | Month | 04 | Day |
Unpublished
Terminated
2013 | Year | 09 | Month | 26 | Day |
2013 | Year | 12 | Month | 07 | Day |
2013 | Year | 12 | Month | 04 | Day |
2016 | Year | 12 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014625