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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047797
Receipt No. R000054484
Scientific Title 3D OCT in Diabetic Macular Edema to Determine Response to Anti-VEGF Drug Therapy
Date of disclosure of the study information 2022/05/18
Last modified on 2022/05/18

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Basic information
Public title 3D OCT in Diabetic Macular Edema to Determine Response to Anti-VEGF Drug Therapy
Acronym 3D OCT in Diabetic Macular Edema to Determine Response to Anti-VEGF Drug Therapy
Scientific Title 3D OCT in Diabetic Macular Edema to Determine Response to Anti-VEGF Drug Therapy
Scientific Title:Acronym 3D OCT in Diabetic Macular Edema to Determine Response to Anti-VEGF Drug Therapy
Region
Japan

Condition
Condition Diabetic Macular Edema
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of Anti-VEGF Drug Efficacy in Diabetic Macular Edema by Retinal resion
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percentage decrease in retinal thickness by site at 1 month after treatment
Key secondary outcomes

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 1. diagnosis of type 2 DM with center-involved DME
2. use of aflibercept or ranibizumab as anti-VEGF therapy for DME
3. macular thickening map image by OCT performed up to 1 month before anti-VEGF drug administration
Key exclusion criteria 1. typical focal DME with ring-shaped hard exudate
2. other retinal diseases, such as retinal vein occlusion or uveitis
3. anti-VEGF therapy with focal/grid laser photocoagulation
4. excessively severe medial opacity that precluded fundal evaluation
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yoshihiro
Middle name
Last name Takamura
Organization university of Fukui Hospital
Division name Ophthalmology
Zip code 9101193
Address 23-3, matcuoka shimoaituki, eiheiji-cho, yoshida-gun, Fukui
TEL 0776-61-8403
Email ytakamura@hotmail.com

Public contact
Name of contact person
1st name Yutaka
Middle name
Last name Yamada
Organization university of Fukui Hospital
Division name Ophthalmology
Zip code 9101193
Address 23-3, matcuoka shimoaituki, eiheiji-cho, yoshida-gun, Fukui
TEL 0776-61-8403
Homepage URL
Email yyutaka@u-fukui.ac.jp

Sponsor
Institute university of Fukui Hospital
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization university of Fukui Hospital
Address 23-3, matcuoka shimoaituki, eiheiji-cho, yoshida-gun, Fukui
Tel 0776-61-8403
Email ytakamura@hotmail.com

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
2022 Year 05 Month 18 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 46
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
2020 Year 12 Month 01 Day
Date of IRB
2022 Year 05 Month 18 Day
Anticipated trial start date
2022 Year 05 Month 18 Day
Last follow-up date
2024 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective observational study

Management information
Registered date
2022 Year 05 Month 18 Day
Last modified on
2022 Year 05 Month 18 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054484

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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