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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025490
Receipt No. 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 2016/12/31

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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
Middle name
Last name Masahiko Shimura
Organization Tokyo Medical University, Hachioji Medical Center
Division name Depatment of Ophthalmology
Zip code
Address 1163 Tate-machi, Hachioji, Tokyo
TEL 0426655611
Email masahiko@v101.vaio.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Shimura
Organization Tokyo Medical University, Hachioji Medical Center
Division name Depatment of Ophthalmology
Zip code
Address 1163 Tate-machi, Hachioji, Tokyo
TEL 0426655611
Homepage URL
Email masahiko@v101.vaio.ne.jp

Sponsor
Institute Department of Ophthalmology
Tokyo Medical University, Hachioji Medical Center
Institute
Department

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
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 01 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 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 02 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 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
2016 Year 12 Month 31 Day


Link to view the page
URL(English) https://upload.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


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