UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059171 |
|---|---|
| Receipt number | R000067628 |
| Scientific Title | Correlation Between Non-Perfusion Areas and Retinal Sensitivity in Diabetic Macular Edema Resolved After Anti-VEGF Therapy |
| Date of disclosure of the study information | 2025/09/24 |
| Last modified on | 2025/09/24 00:15:11 |
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Basic information
Public title
Correlation Between Non-Perfusion Areas and Retinal Sensitivity in Diabetic Macular Edema Resolved After Anti-VEGF Therapy
Acronym
Correlation Between Non-Perfusion Areas and Retinal Sensitivity in Diabetic Macular Edema Resolved After Anti-VEGF Therapy
Scientific Title
Correlation Between Non-Perfusion Areas and Retinal Sensitivity in Diabetic Macular Edema Resolved After Anti-VEGF Therapy
Scientific Title:Acronym
Correlation Between Non-Perfusion Areas and Retinal Sensitivity in Diabetic Macular Edema Resolved After Anti-VEGF Therapy
Region
| Japan |
Condition
Condition
diabetic retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between retinal ischemia and sensitivity in patients with diabetic macular edema (DME) who achieved edema remission through anti-VEGF treatment.
Basic objectives2
Others
Basic objectives -Others
Observational study (association analysis)
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Avascular area in OCTA, retinal visual field sensitivity in Humphrey perimeter
Key secondary outcomes
A comparison of vascular density in the avascular area when past macular edema was present and when the edema had subsided was performed.
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 retinopathy who had previously received anti-VEGF drug treatment for diabetic macular edema at each research institution within the period up to the date of ethics committee approval, and who have not experienced recurrence of edema for six months without anti-VEGF drug treatment, and who underwent visual field measurement using OCTA and Humphrey perimeter.
There are no restrictions on other DME treatments, such as anti-VEGF drugs or laser therapy.
Key exclusion criteria
1. Patients who declined to participate in this study
2. Patients with retinal diseases other than DME (e.g., retinal vein occlusion)
3. Patients with neovascular glaucoma
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | yuki |
| Middle name | |
| Last name | sanada |
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
akasakasakasusa@gmail.com
Public contact
Name of contact person
| 1st name | yuki |
| Middle name | |
| Last name | sanada |
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
akasakasakasusa@gmail.com
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
akasakasakasusa@gmail.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
| 2025 | Year | 09 | Month | 24 | 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
| 2024 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing particular
Management information
Registered date
| 2025 | Year | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067628
