UMIN-CTR Clinical Trial

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

Condition
Condition	Polypoidal Choroidal Vasculopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of aflibercept on best-collected visual acuity in patients with PCV by 3 injections for loading phase and then bimonthly injections
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Proportion of improved/maintained visual acuity at month 12
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 (FA), 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	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Eylea (aflibercept)
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) wAMD on FA, ICGA and OCT 3) PCV on fundus photography and ICGA 4) Treatment-na&iuml;ve PCV 5) BCVA>0.05
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 (<3 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
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tatsuro Ishibshi
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Ophthalmology
Zip code
Address	3-1-1 Maidashi, Higashi-Ku, Fukuoka
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Yuji Oshima
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
Email	yuji@eye.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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

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

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 02 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	Completed
Date of protocol fixation	2013 Year 03 Month 21 Day
Date of IRB	2013 Year 05 Month 21 Day
Anticipated trial start date	2013 Year 07 Month 02 Day
Last follow-up date	2015 Year 05 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 07 Month 02 Day
Last modified on	2021 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012989