UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050623 |
|---|---|
| Receipt number | R000057577 |
| Scientific Title | Observational study on changes in renal function after new intravitreal drug administration |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/03/18 14:39:26 |
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Basic information
Public title
Observational study on changes in renal function after new intravitreal drug administration
Acronym
Observational study on renal function after new intravitreal drug administration
Scientific Title
Observational study on changes in renal function after new intravitreal drug administration
Scientific Title:Acronym
Observational study on changes in renal function after new intravitreal drug administration
Region
| Japan |
Condition
Condition
age-related macular degeneration, branch retinal vein occlusion, pathologic myopia, diabetic retinopathy
Classification by specialty
| Endocrinology and Metabolism | Nephrology | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect the presence and timing of renal dysfunction after intravitreal drug intraocular administration.
Basic objectives2
Others
Basic objectives -Others
To clarify events that are unknown whether they could actually occur or not.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Urinary Albumin Quantitative Changes
Key secondary outcomes
Incidence of advanced urinary albumin determination
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects diagnosed with choroidal neovascularization associated with age-related macular degeneration, macular edema associated with retinal vein occlusion, choroidal neovascularization in pathological myopia, or diabetic macular edema (because intravitreal drugs including anti-VEGF drugs may be administered).
2. Subjects who are able to visit the hospital during the study period (because it is necessary to continue to visit the hospital for at least one year).
3. Subjects who need to receive a new intravitreal drug including anti-VEGF drugs (because the data required for this study cannot be obtained if the drug has been administered even once at another hospital).
4. The lower limit of the subjects' age was set at 20 years and the upper limit at 90 years (because continuous outpatient visits for one year were considered possible.)
Key exclusion criteria
Pregnant women or women who may be pregnant.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Toshihide |
| Middle name | |
| Last name | Kurihara |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353134132
kurihara@z8.keio.jp
Public contact
Name of contact person
| 1st name | Norimitsu |
| Middle name | |
| Last name | Ban |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353134132
Homepage URL
nban@keio.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Others
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
Keio University School of Medicine, Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2023 | Year | 04 | Month | 01 | 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
| 2022 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
This is an observational study and subjects who meet the criteria can be enrolled.
Management information
Registered date
| 2023 | Year | 03 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057577
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/03/18 | UMIN2024Mar18登録プロトコル.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/09/17 | UMIN登録CRFひな形.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/03/18 | UMIN登録データ2024Mar18.xlsx |
