UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy evaluation of intravitreal aflibercept for polypoidal choroidal vasculopathy
Title of the study (Brief title)	Efficacy evaluation of intravitreal aflibercept for polypoidal choroidal vasculopathy
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the best corrected visual acuity 12 months after intravitreal aflibercept treatment, which was performed with 3 monthly injections followed by 4 bimonthly ones.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Ratio of patients who achieved less than 15 letters loss in ETDRS chart
Key secondary outcomes	Change of visual acuity in ETDRS chart between baseline and 6 or 12 months after treatment Ratio of polyp regression on ICGA at 6 or 12 months after treatment Ratio of abnormal vascular network regression on ICGA at 6 or 12 months after treatment Change of foveal thickness on OCT between baseline and 6 or 12 months after treatment Change of exudative lesions between baseline and 6 or 12 months after treatment

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	1) Study period start at the day of the first injection of aflibercept. 2) Aflibercept is injected 3 monthly as an induction phase. 3) Aflibercept is injected 4 bimonthly as a maintenance phase following induction phase. 4) Injection procedure or follow-up regimen is based on guideline in each affiliation.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with informed consent 2) Patients with both sexes whose age are 50 or over 3) Patients with exudative age-related macular degeneration 4) Patients who is diagnosed as PCV on fundus photo or ICGA 5) Patients without previous treatment for PCV 6) Dicimal visual acuity of the study eye is between 0.1 and 0.7
Key exclusion criteria	1) Lesion size >=12 disc area (1 disc rea is 30.5mm2). 'Lesion' includes hemorrhage, scar, and CNV. 2) Area of subretinal hemorrage in study eye>=50% of total lesion area 3) Area of scar or fibrosis in study eye>=50% of total lesion area 4) RPE tear in study eye 5) Stage 3 or 4 macular hole in study eye 6) Administration of triamcinolone to study eye within 6 months prior to this study 7) Administration of dexamethasone to study eye within 30 days prior to this study 8) Intraocular surgery to study eye within 6 months prior to this study 9) Any history of vitrectomy in study eye 10) Any inflammation or infection in intra-or extra-ocular tissue in either eye 11) History of uveitis in either eye 12) Allergy to fluorescein, indocyanine or iodine 13) pregnant women and nursing mothers 14) Patients who were judged by docters to be inappropriate for this study
Target sample size	30

Research contact person
Name of lead principal investigator	Akira Arakawa
Organization	Yokohama City University Medical Center
Division name	Ophthalmology
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	a_ara@yokohama-cu.ac.jp

Public contact
Name of contact person	Akira Arakawa
Organization	Yokohama City University Medical Center
Division name	Ophthalmology
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	a_ara@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Bayer HealthCare
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	JAPAN

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

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	横浜市立大学附属市民総合医療センター（神奈川県）

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 15 Day
Anticipated trial start date	2013 Year 04 Month 15 Day
Last follow-up date	2014 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/26710307
Results
Other related information

Management information
Registered date	2013 Year 04 Month 10 Day
Last modified on	2016 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012225