UMIN-CTR Clinical Trial

Basic information
Public title	The change of retinal sensitivity with intravitreal injection of aflibercept for wet type of age-related macular degeneration.
Acronym	The change of retinal sensitivity with IVA for AMD
Scientific Title	The change of retinal sensitivity with intravitreal injection of aflibercept for wet type of age-related macular degeneration.
Scientific Title:Acronym	The change of retinal sensitivity with IVA for AMD
Region	Japan

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

Objectives
Narrative objectives1	To investigate the visual function from various angle with the analysis of retinal sensitivity after intravitreal injection of aflibercept for wet type of age-related macular degeneration.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The change amount of retinal sensitivity at six month from base line after initial therapy of intravitreal injection of aflibercept for wet type of age-related macular degeneration
Key secondary outcomes	1.The ratio of patients with improvement or preservation of visual acuity after intravitreal injection of aflibercept 2.The change amount of visual aquity at 1,3,6,12 months from base line 3.The change amount of central foveal thickness at 1,3,6,12 months from base line 4.The ratio of patients with subretinal or intraretinal exdative change at 6 and 12 months 5.The change amount of retinal sensitivity at 1,3 and 12 months from base line

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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)patients who received informed consent and agreed the investigation 2)man or woman 50 years or older 3)patiens with typical AMD or polypoidal chorodal vasculopathy 4)treatment naive for AMD 5)decimal visual acuity within 0.1 to 1.2
Key exclusion criteria	1.Patients who need to undergo intravitreal injection of aflibercept for their both eyes. 2.The lesion is more than 12 disc diameter area with fluorecein angiography 3.Subretinal hemorrhage with 50 percent or more of the lesion area 4.Subretinal scar or fibrosis with 50 percent or more of the lesion area 5.retinal pigment epithelium tear 6.patients who had past stage 3 or 4 macular hole 7.patients who received the therapy with triamcinolone acetonide within 6 months 8.patients who received the therapy with Dexamethasone within 30 days 9.patients who received intra occular surgery within 6 months 10.patients who received pars plana vitrectomy or submacular surgery 11.patinets with intra or external occular infection or inflamation 12.patients with uveitis in any eye 13.fluorescein or indocianine green alergy 14.pregnancy or possibility of pregnancy or woman who are lactating 15.patient who are judged unsuitable for the investigation by the doctor
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shuichi Yamamoto
Organization	Chiba University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Science
Zip code
Address	1-8-1 Inohana,Chuo-ku,Chiba 2608670,Japan
TEL	043-222-7171
Email	shuyama@faculty.chiba-u.jp

Public contact
1st name of contact person	1st name Middle name Last name Masayasu Kitahashi
Organization	Chiba University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Science
Zip code
Address	1-8-1 Inohana,Chuo-ku,Chiba 2608670,Japan
TEL	043-222-7171
Homepage URL
Email	kitahashi@faculty.chiba-u.jp

Sponsor
Institute	Department of Ophthalmology and Visual Science Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Ophthalmology and Visual Science Chiba University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	千葉大学医学部附属病院眼科(千葉県）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 01 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	2016 Year 09 Month 01 Day
Date of IRB	2016 Year 08 Month 31 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2019 Year 03 Month 09 Day
Date of closure to data entry	2019 Year 03 Month 09 Day
Date trial data considered complete	2019 Year 03 Month 11 Day
Date analysis concluded	2019 Year 03 Month 14 Day

Other
Other related information	prospective observentional study

Management information
Registered date	2014 Year 12 Month 01 Day
Last modified on	2019 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018394