UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between contrast sensitivity, vision-related quality of life and foveal microstructure in patients with diabetic macular edema following aflibercept therapy.
Title of the study (Brief title)	Relationship between contrast sensitivity, vision-related quality of life and foveal microstructure in patients with diabetic macular edema following aflibercept therapy.
Region	Japan

Condition
Condition	Diabetic macular edema
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of aflibercept on contrast sensitivity and vision-related quality of life in patients with diabetic macular edema.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	Contrast sensitivity from baseline to 12 month
Key secondary outcomes	Visual acuity from baseline to 12 month Central macular thickness(CMT) from baseline to 12 month Contrast sensitivity at every visit Vision-related quality of life (VR-QOL) from baseline to 12 month

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	Prevention
Type of intervention	Other
Interventions/Control_1	visual acuity with the Landolt chart at every visit Central macular thickness (CMT) by Spectral Domain-OCT at every visit Contrast sensitivity by CSV-1000LV chart at every visit Vision-related quality of life (VR-QOL) with the National Eye Institute 25-item visual function questionnaire (NEI VFQ-25) at pretreatment, 3, 6, and 12 month Adverse eventsr/ serious adverse events
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	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	1.Adults more than 20 years with type 1 or 2 diabetes mellitus 2.Subjects with DME secondary to diabetes mellitus involving the center of the macula defined as the area of the center subfield of OCT in the study eye 3.Decrease in vision determined to be primarily the result of DME in the study eye 4.BCVAmore than 24 letters 5.Central retinal thickness as assessed by OCT of more than 300 in the study eye 6.Willing and able to comply with clinic visits and study related procedures 7.Provide a signed informed consent form after receiving a explanation about this study
Key exclusion criteria	(1)The study eye is better than fellow eye (2)History of vitreoretinal surgery (3)Laser photocoagulation in the study eye within 90 days before Day 1 (4)More than 1 treatment with Direct laser/grid laser (5)Previous use of intraocular or periocular corticosteroids in the study eye within 120 days (6)Previous treatment with anti-angiogenic drugs in either eye within 90 days (7)Proliferative diabetic retinopathyin the study eye, (8)History of idiopathic or autoimmune uveitis (9)Any intraocular surgerywithin 90 days before Day 1 (10)Aphakia (11)Vitreomacular traction (12)Current iris neovascularization, vitreoushemorrhage, or tractional retinal detachment (13)Pre-retinal fibrosis (14)Structural damage to the center of the macula (15)History of endophthalmitis (16)Infectious blepharitis, keratitis,scleritis or conjunctivitis (17)Uncontrolled graucoma (18)High intraocular pressure in the study ey (19)High myopia (20)History of disease that can result in decreased visual acuity (21)Only one functional eye (22)Ocular media insufficient to obtain fundus and OCT images in the study eye (23)Serious systemic infection (24)Administration of systemic anti-angiogenic agents within 180 days before day 1 (25)Uncontrolled blood pressure (26)Uncontrolled diabetes mellitus (27)History of cerebrovascular accident and/or Myocardial infarction within 180 days before day 1 (28)Renal failure (29)Systemic disease patients who need treatment that may affect outcomes (30)Pregnant or breast-feeding women (31)Female subjects wish for a pregnancy within the intended treatment period (32)Allergy to fluorescein (33)Hypersensitive to aflibercept (34)Previous participation in any studies of investigational drugs within 30 days preceding Day 1 (35)Subjects who judged by a investigator to be inappropriate for the study
Target sample size	20

Research contact person
Name of lead principal investigator	Fumiki Okamoto
Organization	University of Tsukuba
Division name	Department of Ophthalmology, Faculty of Medicine
Address	1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575 Japan
TEL	029-853-3148
Email	fumiki-o@md.tsukuba.ac.jp

Public contact
Name of contact person	Fumiki Okamoto
Organization	University of Tsukuba
Division name	Department of Ophthalmology, Faculty of Medicine
Address	1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575 Japan
TEL	029-853-3148
Homepage URL
Email	fumiki-o@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Bayer
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	筑波大学附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 08 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 02 Month 28 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2018 Year 02 Month 28 Day
Date of closure to data entry	2018 Year 03 Month 05 Day
Date trial data considered complete	2018 Year 03 Month 05 Day
Date analysis concluded	2018 Year 05 Month 01 Day

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

Management information
Registered date	2015 Year 12 Month 24 Day
Last modified on	2018 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023472