UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025490
Receipt number R000029333
Scientific Title Evaluation of morphological-based treatment regimen of aflibercept in patients with diabetic macular edema
Date of disclosure of the study information 2017/01/01
Last modified on 2020/03/28 21:13:14

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Basic information

Public title

Evaluation of morphological-based treatment regimen of aflibercept in patients with diabetic macular edema

Acronym

Morphological-based aflibercept treatment for DME

Scientific Title

Evaluation of morphological-based treatment regimen of aflibercept in patients with diabetic macular edema

Scientific Title:Acronym

Morphological-based aflibercept treatment for DME

Region

Japan


Condition

Condition

Diabetic Macular Edema

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate unique treatment regimen of aflibercept for diabetic macular edema, morphological based monthly injections as loading, and subsequent bimonthly injections as maintenance phase.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Improvement of logMAR visual acuity at 12 months

Key secondary outcomes

Ratio of patients who gained VA >logMAR0.2 at 12 months
Dynamic change of central macular thicknes (CMT) during the clinical course of 12 months
The requied number of initial contiuous injections of aflibercept to obtain CMT <300 micrometer


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

patients with diabetic macular edema with central macular thickness more than 400 micrometer and best corrected visual acuity between logMAR 0.15 and 1.2

Key exclusion criteria

Vitrectomized eye
Previous anti-VEGF therapy
Previous any treatment for DME before 90 days
Pregnant or potentially pregnant
Uncontrolled general condition
Ocular inflammation
Active proliferative diabetic retinopathy

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Masahiko
Middle name
Last name Shimura

Organization

Tokyo Medical University, Hachioji Medical Center

Division name

Depatment of Ophthalmology

Zip code

1930998

Address

1163 Tate-machi, Hachioji, Tokyo

TEL

0426655611

Email

masahiko@v101.vaio.ne.jp


Public contact

Name of contact person

1st name Masahiko
Middle name
Last name Shimura

Organization

Tokyo Medical University, Hachioji Medical Center

Division name

Depatment of Ophthalmology

Zip code

1850012

Address

1163 Tate-machi, Hachioji, Tokyo

TEL

0426655611

Homepage URL


Email

masahiko@v101.vaio.ne.jp


Sponsor or person

Institute

Department of Ophthalmology
Tokyo Medical University, Hachioji Medical Center

Institute

Department

Personal name



Funding Source

Organization

Byer Pharmaceutical

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

Institutional Review Board in Tokyo Medical University Hachioji Medical Center

Address

1163 Tate-machi, Hachioji, Tokyo

Tel

0426655611

Email

masahiko@v101.vaio.ne.jp


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 01 Month 01 Day


Related information

URL releasing protocol

under construction

Publication of results

Published


Result

URL related to results and publications

under construction

Number of participants that the trial has enrolled

49

Results

Mean improvement from baseline visual acuity at 12 month was 0.17 plus/minus 0.24 logMAR (8.5 letters). Proportion of eyes gained more than 0.3 logMAR was 30.6%, and lost over 0.3 logMAR was 4.1%. Eighteen eyes (36.7%) showed prompt regression of CMT soon after the 1st aflibercept injection, while 7 eyes (14.3%) required 6 continuous injections at loading phase. Total required number of aflibercept injection averaged 7.14 plus/minus 1.08 times.

Results date posted

2020 Year 03 Month 28 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

patients with DME, of which central macular thickness (CMT) > 400 micro meter and best corrected visual acuity (BCVA) ranged 0.3-1.0 logMAR.

Participant flow

56 patients were recrtuited and 49 cases were completed in this study

Adverse events

There were no systemic adverse effect. Also, no ocular adverse effects in relation to this study protocol were not reported.

Outcome measures

Primary outcome measures
Averaged improvement of visual acuity from baseline
secondary outcome measures
proportion of eyes gained visual acuity more than 0.3 logMAR
Averaged reduction of macular thickness from baseline
require number of drug injection for obtaining macular thickness less than 300 micro meter

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 02 Month 01 Day

Date of IRB

2017 Year 01 Month 25 Day

Anticipated trial start date

2017 Year 02 Month 01 Day

Last follow-up date

2019 Year 01 Month 23 Day

Date of closure to data entry

2019 Year 02 Month 01 Day

Date trial data considered complete

2019 Year 02 Month 14 Day

Date analysis concluded

2019 Year 02 Month 28 Day


Other

Other related information

As a initial phase, initial monthly aflibercept injections up to CMT less than 300 mocrometer but maximum 5 continuous injections
After that, as a maintenance phase, subsequent bimonthly aflibercept injections


Management information

Registered date

2016 Year 12 Month 31 Day

Last modified on

2020 Year 03 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029333


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name