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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018315
Receipt No. R000021196
Scientific Title Effect of Intravitreal Aflibercept Injection on Microaneurysm in Patients with Diabetic Macular Edema
Date of disclosure of the study information 2015/07/14
Last modified on 2018/08/15

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Basic information
Public title Effect of Intravitreal Aflibercept Injection on Microaneurysm in Patients with Diabetic Macular Edema
Acronym Effect of Intravitreal Aflibercept Injection
Scientific Title Effect of Intravitreal Aflibercept Injection on Microaneurysm in Patients with Diabetic Macular Edema
Scientific Title:Acronym 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
1st name
Middle name
Last name Masahiko Sugimoto, MD, PhD
Organization Mie University
Division name Department of Ophthalmology
Zip code
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
1st name
Middle name
Last name Masahiko Sugimoto, MD, PhD
Organization Mie University
Division name Department of Ophthalmology
Zip code
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)

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 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

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
2015 Year 06 Month 04 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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