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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020787
Receipt No. 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

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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
Institute Shiga University of Medical Science
Institute
Department

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
URL(English) https://upload.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


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