UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044287 |
|---|---|
| Receipt number | R000050584 |
| Scientific Title | Evaluation of general condition before and after vitreous anti-VEGF drug administration for diabetic macular edema |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2023/04/03 17:31:11 |
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Basic information
Public title
Evaluation of general condition before and after vitreous anti-VEGF drug administration for diabetic macular edema
Acronym
Evaluation of general condition before and after vitreous anti-VEGF drug administration for diabetic macular edema
Scientific Title
Evaluation of general condition before and after vitreous anti-VEGF drug administration for diabetic macular edema
Scientific Title:Acronym
Evaluation of general condition before and after vitreous anti-VEGF drug administration for diabetic macular edema
Region
| Japan |
Condition
Condition
Diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will use questionnaires to evaluate changes in disease perception associated with ophthalmic interventions, and evaluate them in conjunction with actual blood sampling data such as HbA1c and findings such as visual acuity and central retinal thickness before and after ophthalmic interventions to verify whether diabetes control improves with ophthalmic interventions.
Basic objectives2
Others
Basic objectives -Others
change of consciousness
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare HbA1c before and after intravitreal anti-VEGF drug administration, and see if HbA1c decreases.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes with thickening of the central macula, which was defined as a central retinal thickness of 300 micrometer or more in the central subfield based on optical coherence tomography due to DME, were eligible for this study.
Key exclusion criteria
Active endophthalmitis or infection in either eye, uncontrolled glaucoma in either eye, or a history of stroke.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | yoshihiro |
| Middle name | |
| Last name | takamura |
Organization
Fukui University
Division name
Ophthalmology
Zip code
9101193
Address
23-3 Matsuoka-Shimogetsu, Eiheiji-cho, Yoshida-gun, Fukui Prefecture
TEL
0776-61-8403
fganka@med.u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | hideyuki |
| Middle name | |
| Last name | oshima |
Organization
Fukui University
Division name
Ophthalmology
Zip code
9101193
Address
23-3 Matsuoka-Shimogetsu, Eiheiji-cho, Yoshida-gun, Fukui Prefecture
TEL
0776-61-8403
Homepage URL
fganka@med.u-fukui.ac.jp
Sponsor or person
Institute
Fukui University
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukui University
Address
Ophthalmology
Tel
0776-61-8403
fganka@med.u-fukui.ac.jp
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 | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2077-0383/11/16/4659
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2077-0383/11/16/4659
Number of participants that the trial has enrolled
112
Results
Central retinal thickness and visual acuity significantly improved at three months and through-out the period after initiating therapy ; a significant change in HbA1c was not found. A total of 59.8% of patients became more active in glycemic control through exercise and diet therapy after initiating therapy, resulting in a significantly lower HbA1c at 6, 12, and 18 months compared to patients who did not.
Results date posted
| 2023 | Year | 04 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We enrolled 112 patients who had been followed for two years and completed the questionnaire. Of these, 80 were men and 32 were women. The mean age was 67.0 +- 10.3 years and the duration of diabetes was 12.7 +- 10.6 years.
Participant flow
Patients with type 2 diabetes with thickening of the central macula, defined as a central retinal thickness (CRT) >=300 micrometre in the central subfield based on optical coherence tomography (OCT) due to DME, were eligible for this study. The main exclusion criteria were: (1) <20 years of age; (2) active intraocular inflammation or infection in either eye; (3) uncontrolled glaucoma in either eye; and (4) a history of stroke.
Adverse events
There were no adverse events.
Outcome measures
HbA1c at baseline was 7.40 +- 1.08%, with no significant change over the two years .
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 05 | Month | 21 | Day |
Last modified on
| 2023 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050584
