UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Intravitreal Aflibercept Injection on Microaneurysm in Patients with Diabetic Macular Edema
Title of the study (Brief title)	Effect of Intravitreal Aflibercept Injection
Region	Japan

Condition
Condition	Diabetic Macular Edema
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether intravitreal aflibercept injection (IVA) as monotherapy is effective in reducing Microaneurysms(MAs) in patients with DME and whether changes in MAs and reduced edema have an impact on visual function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Baseline change of MA counts and brightness assessed by FA
Key secondary outcomes	1. Baseline change of Visual acuity by logMAR 2. Baseline change of Central Retinal thickness (CRT) by OCT 3. Electroretinography(ERG) 4. Baseline change of DRSS 5. Safety

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Adults (age over 20 years) with type 1 or 2 diabetes mellitus who have provided informed consent 2)Subjects with the following retinopathy as shown by fundoscopy with pupil dilation and also with MAs with fluorescein leakage within the retinal arcades by fluorescein angiography 3)Best corrected visual acuity (BCVA) of over 20/320 in ETDRS letter score 4)CRT of over 300 um as measured by the retinal map (1-mm field) of OCT
Key exclusion criteria	1)Panretinal or macular laser photocoagulation (including grid photocoagulation) within 3 months 2)Macular ischemia involving the center of the macula that is likely to preclude improvement in BCVA 3)Vitreomacular traction evident biomicroscopically or on OCT 4)Active proliferative diabetic retinopathy (characterized by any of the following: vitreous hemorrhage, preretinal hemorrhage, disc neovascularization, retinal neovascularization, and proliferative membrane or tractional retinal detachment with neovascularization) 5)Glaucoma or optic atrophy 6)History of any vitreous surgery 7)Aphakia 8)Treatment with any drug injected into the vitreous cavity or around the eye within 3 months 9)Cataract that prevents fundus examinations required for the study 10)Cataract surgery within 3 months 11)Severe systemic conditions such as severe heart disease and cerebrovascular disorder 12)Significant renal impairment defined as a serum creatinine level of over 2.0 mg/dL or Stage 3B or greater overt nephropathy (including subjects requiring hemodialysis) 13)Uncontrolled hypertension (systolic over 180, diastolic over110 mmHg) 14)Uncontrolled diabetes mellitus (HbA1c over 10% [NGSP]) 15)Ocular inflammation including trace or above in the study eye 16)Pregnant or breast-feeding women.
Target sample size	30

Research contact person
Name of lead principal investigator	Masahiko Sugimoto, MD, PhD
Organization	Mie University
Division name	Department of Ophthalmology
Address	2-174, Edobashi, Tsu-shi, Mie, Japan
TEL	059-232-1111
Email	sugmochi@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Masahiko Sugimoto, MD, PhD
Organization	Mie University
Division name	Department of Ophthalmology
Address	2-174, Edobashi, Tsu-shi, Mie, Japan
TEL	059-232-1111
Homepage URL
Email	sugmochi@clin.medic.mie-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Mie University
Institute
Department

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	三重大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 04 Day
Anticipated trial start date	2015 Year 06 Month 04 Day
Last follow-up date
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	None

Management information
Registered date	2015 Year 07 Month 14 Day
Last modified on	2018 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021196