UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of optimum timing for intravitreal injection of aflibercept for age-related macular degeneration
Title of the study (Brief title)	Evaluation of optimum timing for intravitreal injection of aflibercept for age-related macular degeneration
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the visual outcome of treat and extend regimen(TAE) in managing wet age-related macular degeneration with intravitreal aflibercept.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Proportion of eyes at week 52 that maintained best-corrected visual acuity (BCVA; lost <15 letters from baseline); change from baseline in BCVA.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intravitreal aflibercept with traet and extend regimen
Interventions/Control_2	Intravitreal aflibercept every 8 weeks
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient with new-onset, active, subfoveal, choroidal neovascularization lesions (or juxtafoveal with leakage affecting the fovea) secondary to age-related macular degeneration
Key exclusion criteria	Presence of other causes of CNV, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye. History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye. Active intraocular inflammation in the study eye. Active ocular or periocular infection in study eye. Uncontrolled glaucoma in the study eye. Prior treatment with anti VEGF therapy in the study eye. History of myocardial infarction or stroke in the past 3 months.
Target sample size	40

Research contact person
Name of lead principal investigator	Hidenobu Tanihara
Organization	Faculty of life sciences, Kumamoto university
Division name	Department of ophthalmology
Address	1-1-1,honjyo,chuo-ku,kumamoto,kumamoto,japan
TEL	096-344-2111
Email	ganka@kumamoto-u.ac.jp

Public contact
Name of contact person	Yasuya Inomata
Organization	Faculty of life sciences, Kumamoto university
Division name	Department of ophthalmology
Address	1-1-1,honjyo,chuo-ku,kumamoto,kumamo
TEL	096-344-2111
Homepage URL
Email	inoyas@kxb.biglobe.ne.jp

Sponsor
Institute	Faculty of life sciences, Kumamoto university
Institute
Department

Funding Source
Organization	Faculty of life sciences, Kumamoto university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	熊本大学医学部附属病院（熊本県）、出田眼科医院（熊本県）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 07 Day
Anticipated trial start date	2014 Year 07 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2016 Year 10 Month 31 Day
Date analysis concluded	2016 Year 11 Month 01 Day

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

Management information
Registered date	2014 Year 08 Month 25 Day
Last modified on	2017 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015409