UMIN-CTR Clinical Trial

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

Diabetic Macular Edema

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Ophthalmology, Mie University

Institute

Department

Personal name

Organization

Bayer Yakuhin, Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

三重大学医学部附属病院

Date of disclosure of the study information

2015

Year

07

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

None

Registered date

2015

Year

07

Month

14

Day

Last modified on

2018

Year

08

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021196