UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027771
Receipt number R000031572
Scientific Title Investigation of the treat-and-extend protocol with Aflibercept in combination with retinal photocoagulation in patients with diabetic macula edema(extension study)
Date of disclosure of the study information 2017/07/01
Last modified on 2017/09/04 18:57:52

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Basic information

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

Condition

Diabetic macula edema

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

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


Assessment

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


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Shinshu University Department of ophthalmology

Institute

Department

Personal name



Funding Source

Organization

Bayer Yakuhin

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 01 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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name