UMIN-CTR Clinical Trial

Public title

Investigation of the treat-and-extend protocol with Aflibercept in combination with retinal photocoagulation in patients with diabetic macula edema(extension study)

Acronym

Investigation of the T&E protocol with IVA in combination with retinal photocoagulation in DME patients(extension study)

Scientific Title

Investigation of the treat-and-extend protocol with Aflibercept in combination with retinal photocoagulation in patients with diabetic macula edema(extension study)

Scientific Title:Acronym

Investigation of the T&E protocol with IVA in combination with retinal photocoagulation in DME patients(extension study)

Region

Japan

Condition

Diabetic macula edema

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the efficacy of the treat-and-extend protocol with Aflibercept in combination with retinal photocoagulation in patients with diabetic macula edema.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

Central retinal thickness (CRT) measured on optical coherence tomography (OCT) and visual acuity

Key secondary outcomes

Number of intravitreal injections of aflibercept and safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Aflibercept (genetical recombination) will be administered by intravitreal injection at a dose of 2 mg (0.05 mL) at intervals of at least 4 weeks.

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

Patients with type 1 or type 2 diabetes mellitus 20 years of age or older
Patients with fovea involving diabetic macular edema (judged with central subfield thickness on OCT)
Patients with reduced visual acuity associated with diabetic macular edema
Patients whose best corrected visual acuity is more than 20/320 (24 letters) by the ETDRS visual acuity test.
Patients with a central retinal thickness (CRT) of 300 um or more on the OCT retinal map (measured in mm) as an objective finding
Patients who are willing and able to visit the study site, as scheduled, and undergo scheduled examinations in this study
Patients who can provide written voluntary consent to participate in this study after receiving adequate explanation

Key exclusion criteria

The condition of the fellow eye is worse than that of the study eye.
A history of vitreous surgery, including encircling buckling
Any retinal photocoagulation treatment within 90 days
Topical corticosteroid treatment within 120 days
Treatment with injection of any anti VEGF agent into the study eye within 90 days
Highly active, proliferative diabetic retinopathy in the study eye
A history of uveitis
Aphakic eyes
A history of any intraocular surgery in the study eye within the previous 90 days
It is considered difficult to improve visual acuity due to morphological changes
Glaucoma with poor IOP control, a history of glaucoma filtering surgery, or scheduled filtering surgery in the study eye
IOP of the study eye: more than 25 mmHg
Myopia of -8D or greater
Optic media in which it is difficult to obtain fundus photographs or OCT images
Severe systemic infections at baseline
Systemic anticoagulation therapy within 180
Poorly controlled diabetes mellitus
Poorly controlled hypertension
A history of cerebrovascular accident and/or myocardial infarction within 180 days
Patients on dialysis and patients with renal failure requiring dialysis

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Toshinori Murata

Organization

Shinshu University

Division name

Department of ophthalmology

Zip code

Address

Asahi,Matsumoto,390-8621 Japan

TEL

+81-263-37-2664

Email

murata@shinshu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yuichi Toriyama

Organization

Shinshu University

Division name

Department of ophthalmology

Zip code

Address

Asahi,Matsumoto,390-8621 Japan

TEL

+81-263-37-2664

Homepage URL

Email

ytoriyama@shinshu-u.ac.jp

Institute

Shinshu University Department of ophthalmology

Institute

Department

Personal name

Organization

Bayer Yakuhin

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

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

Date of disclosure of the study information

2017

Year

07

Month

01

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

Preinitiation

Date of protocol fixation

2017

Year

06

Month

06

Day

Date of IRB

Anticipated trial start date

2017

Year

07

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

06

Month

15

Day

Last modified on

2017

Year

09

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031572