UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047797 |
|---|---|
| Receipt number | 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 20:51:40 |
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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
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
yyutaka@u-fukui.ac.jp
Sponsor or person
Institute
university of Fukui Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054484
