UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of intravitreal aflibercept for exudative age-related macular degeneration
Title of the study (Brief title)	Intravitreal aflibercept for AMD
Region	Japan

Condition
Condition	Age-related macular degeneration
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of aflibercept with 3 injections for loading phase and bimonthly injections in patients with wAMD
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Proportion of maintained visual acuity at month 12 (defined as loss of less than 3 lines)
Key secondary outcomes	Change of (best-collected visual acuity) BCVA, central macular thickness, subretinal fluid, contrast sensitivity and mean deviation of humphrey visual field

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	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

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) 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
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 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
Target sample size	30

Research contact person
Name of lead principal investigator	Tsutomu Sakai
Organization	Jikei University School of Medicine
Division name	Department of Ophthalmology
Address	3-25-8 nishishinbashi minatoku tokyo 105-8461 japan
TEL	+81-3-3433-1111
Email	tstmski@jikei.ac.jp

Public contact
Name of contact person	Tsutomu Sakai
Organization	Jikei University School of Medicine
Division name	Department of Ophthalmology
Address	3-25-8 nishishinbashi minatoku tokyo 105-8461 japan
TEL	+81-3-3433-1111
Homepage URL
Email	tstmski@jikei.ac.jp

Sponsor
Institute	Department of Ophthalmology, Jikei University School of Medicine
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 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)

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 10 Month 25 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 07 Month 08 Day
Anticipated trial start date	2013 Year 10 Month 25 Day
Last follow-up date	2015 Year 10 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 25 Day
Last modified on	2016 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014181