UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051104 |
|---|---|
| Receipt number | R000058278 |
| Scientific Title | Impact of Hypoxia Inducible Factor Prolyl Hydoxylase inhibitors on diabetic macular edema and diabetic retinopathy, multicenter study |
| Date of disclosure of the study information | 2023/05/19 |
| Last modified on | 2023/05/19 10:30:27 |
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Basic information
Public title
Impact of HIF-PH inhibitors on diabetic macular edema and diabetic retinopathy, multicenter study
Acronym
Impact of HIF-PH inhibitors on diabetic macular edema, multicenter study
Scientific Title
Impact of Hypoxia Inducible Factor Prolyl Hydoxylase inhibitors on diabetic macular edema and diabetic retinopathy, multicenter study
Scientific Title:Acronym
Impact of HIF-PH inhibitors on DME
Region
| Japan |
Condition
Condition
Renal anemia, diabetic retinopathy, diabetic macular edema
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and evaluate retinal optical coherence tomography (OCT) findings including central retinal thickness, visual acuity, diabetic macular edema, and diabetic retinopathy before and after treatment in diabetic patients initiating HIF-PH inhibitor therapy due to renal anemia. A multicenter prospective study will be conducted to determine whether HIF-PH inhibitor treatment exacerbates diabetic macular edema.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OCT findings including retinal thickness.
visual acuity.
Hemoglobin and other blood tests to assess the degree of anemai.
Key secondary outcomes
The progression of diabetic malular edema and retinopathy (Fundus photography or observation)
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with diabetes mellitus who visited the ophthalmologist from the date of approval by the head of the research institution to March 31, 2028
2. Patients with visual acuity and OCT imaging data before and after the start of HIF-PH administration
Key exclusion criteria
1.Blind in both eyes
2. Inability to perform OCT examination
3. Other patients who are judged as unfit by the ophthalmologist
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Oshima |
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
osm@g.u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Oshima |
Organization
university of Fukui Hospital
Division name
Ophthalmology
Zip code
9101193
Address
23-3, matcuoka shimoaituki, eiheiji-cho, yoshida-gun, Fukui
TEL
776618403
Homepage URL
osm@g.u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
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
Fukui Red Cross Hospital
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
776618403
takamurayoshihiro@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
| 2023 | Year | 05 | Month | 19 | 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
| 2023 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 05 | Month | 19 | Day |
Last modified on
| 2023 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058278
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
