UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Change of focal macular electroretinogram(ERG) in patients with age-related macular degeneration after intravitreal aflibercept(IVA).
Title of the study (Brief title)	Focal macular ERG with wAMD sfter IVA.
Region	Japan

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

Objectives
Narrative objectives1	Primary study objective is to investigate effect of aflibercept on visual acuity and focal macular ERG of japanese wAMD patients at 12M.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	The change of the amplitude of the focal macular ERG at the 12 month from baseline.
Key secondary outcomes	1. Change of BCVA at the 12 month. 2. Change of the amplitude of the focal macular ERG at the 3,6 and 12 month. 3. Change of the retinal thickness evaluated by SD-OCT at the 12 month. 4. Correlation between the focal macular ERG amplitude and BCVA. 5. Correlation between the focal macular ERG amplitude and retinal thickness.

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

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) naive AMD with subfoveal fluid on fluorescent angiography, indocyanine green angiography and/or optical coherence tomography 3) Willingness to provide written informed consent 4) outpatients
Key exclusion criteria	1) Patients with any previous history of treatment of other retinal diseases with pharmacologic agents including verteporfin photodynamic therapy, aflibercept, ranibizumab, bevacizumab or steroids. 2) Clinically significant drug allergy. 3) History of vitrectomy or glaucoma surgery. 4) Presence of RPE tears, angoid streaks or pathologic myopia. 5) Concomitant conditions/diseases including uncontrolled glaucoma and intraocular inflammation 6) Patients who the doctor in charge judges are ineligible for the study
Target sample size	50

Research contact person
Name of lead principal investigator	Shigeki Machida
Organization	Dokkyo Medical University, Koshigaya Hospital
Division name	Department of Ophthalmology
Address	2-1-50, Minami-koshigaya, Koshigaya city, Saitama, Japan
TEL	048-965-1111
Email	machidas@dokkyomed.ac.jp

Public contact
Name of contact person	Shigeki Machida
Organization	Dokkyo Medical University, Koshigaya Hospital
Division name	Department of Ophthalmology
Address	2-1-50, Minami-koshigaya, Koshigaya city, Saitama, Japan
TEL	048-965-1111
Homepage URL
Email	machidas@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University, Koshigaya Hospital Department of Ophthalmology
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)

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	2016 Year 08 Month 15 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 05 Month 01 Day
Anticipated trial start date	2016 Year 05 Month 20 Day
Last follow-up date	2018 Year 04 Month 30 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	2016 Year 08 Month 10 Day
Last modified on	2016 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026913