UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020787
Receipt number R000023955
Scientific Title Efficacy and safety in adequate regimen of aflibercept therapy for patients with diabetic macular edema
Date of disclosure of the study information 2016/01/29
Last modified on 2016/01/29 00:04:26

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Basic information

Public title

Efficacy and safety in adequate regimen of aflibercept therapy for patients with diabetic macular edema

Acronym

Adequate aflibercept therapy for DME

Scientific Title

Efficacy and safety in adequate regimen of aflibercept therapy for patients with diabetic macular edema

Scientific Title:Acronym

Adequate aflibercept therapy for DME

Region

Japan


Condition

Condition

diabetic macular edema

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the adequate regimen in aflibercept intravitreal injection for diabetic macular edema and to evaluate the decrease of number of injections and the improvement in visual acuity

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in best-corrected visual acuity from baseline to six months or 12 months after the initial injection

Key secondary outcomes

Proportion of improvement or no change or worsening in change of best-corrected visual acuity from baseline to six months or 12 months after the initial injection
Change in fluorescin angiography and optical coherence tomography (OCT)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients with diabetic macular edema receive bi-monthly aflibercept intravitreal injections.
When the best-corrected visual acuity worsen more than 0.3 logMAR visual acuity one month after each injection, the patients receive aflibercept injection.

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

Definite retinal thickening due to diabetic macular edema on clinical examination involving the center of the macula assessed to be the main cause of visual loss.
Best-corrected logMAR visual acuity in baseline > 0.22.
Retinal thickness measured on spectral domain optical coherence tomography > 300 micron in the central subfield.

Key exclusion criteria

Anti-VEGF therapy within the prior 3 months.
Retinal photocoagulation within the prior 3 months.
Steroid therapy within the prior 3 months.
Major ocular surgery within the prior 3 months.
A myocardial infarction or other cardiac event requiring hospitalization.
Cerebrovascular accident, transient ischemic attack, or acute congestive heart failure.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osamu Sawada

Organization

Shiga University of Medical Science

Division name

Ophthalmology

Zip code


Address

Seta Tukinowacho, Otsu, Shiga

TEL

077-548-2276

Email

osawada@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Osamu Sawada

Organization

Shiga University of Medical Science

Division name

Ophthalmology

Zip code


Address

Seta Tsukinowacho, Otsu, Shiga

TEL

077-548-2276

Homepage URL


Email

osawada@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Health, Labour and Welfare Ministry

Organization

Division

Category of Funding 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

滋賀医科大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 29 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

Open public recruiting

Date of protocol fixation

2015 Year 01 Month 25 Day

Date of IRB


Anticipated trial start date

2015 Year 01 Month 27 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 05 Month 30 Day

Date trial data considered complete

2018 Year 07 Month 31 Day

Date analysis concluded

2018 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2016 Year 01 Month 29 Day

Last modified on

2016 Year 01 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023955


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name