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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012493
Receipt No. 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

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Basic information
Public title Investigation of clinical efficacy of aflicbercept in patients with polypoidal choroidal vasculopathy (PCV) with resistance of ranibizumab
Acronym Investigation of aflivercept for PCV with resistance of ranibizumab
Scientific Title Investigation of clinical efficacy of aflicbercept in patients with polypoidal choroidal vasculopathy (PCV) with resistance of ranibizumab
Scientific Title:Acronym Investigation of aflivercept for PCV with resistance of ranibizumab
Region
Japan

Condition
Condition Polypoidal choroidal vasculopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of improved/maintained visual acuity at week 52
Regression of polyp on indocyanine green angiography (ICGA)
Key secondary outcomes 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)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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-na&#239;ve PCV
Key exclusion criteria 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.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Yanagi, MD, PhD
Organization Graduate School of Medicine,
The University of Tokyo
Division name Department of Ophthalmology
Zip code
Address 7-3-1 Hongo, Bunkyo-Ku, Tokyo
TEL 03-3815-5411
Email yanagi-tky@umin.org

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Yanagi, MD, PhD
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Ophthalmology
Zip code
Address 7-3-1 Hongo, Bunkyo-Ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email yanagi-tky@umin.org

Sponsor
Institute Department of Ophthalmology, Graduate School of Medicine,
The University of Tokyo
Institute
Department

Funding Source
Organization Bayer Yakuhin Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京大学医学部付属病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 12 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2013 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 12 Month 04 Day
Last modified on
2016 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014625

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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