UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026033 |
|---|---|
| Receipt number | R000029726 |
| Scientific Title | The relationship between choroidal structure and protein uria in patients with diabetetic macular edema |
| Date of disclosure of the study information | 2017/02/10 |
| Last modified on | 2020/02/11 11:46:17 |
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Basic information
Public title
The relationship between choroidal structure and protein uria in patients with diabetetic macular edema
Acronym
Choroidal structure in patients with diabetic macular edema and protein uria
Scientific Title
The relationship between choroidal structure and protein uria in patients with diabetetic macular edema
Scientific Title:Acronym
Choroidal structure in patients with diabetic macular edema and protein uria
Region
| Japan |
Condition
Condition
diabetic retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine relationship between the choroidal structure on EDI-OCT images and urine protein to creatinine ratio in patients with diabetic maculapathy.
Basic objectives2
Others
Basic objectives -Others
To examine the influence of protein uria on the efficacy of the treatment for diabetic macular edema
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Choroidal structural paremeters on EDI-OCT images and urine protein to creatinine ratio
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Intravitreal injections of anti-vasular endothelial growth factor agents under treatment regimen with the maximum frequency of monthly injections. Observation with or without interventions are to be performed for 12 months.
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
ETDRS retinal central subfield thickness of >300 micrometer and best-correced visual acuity of >0.05
Key exclusion criteria
Patients or eyes with following conditions are to be excluded.
1. patients under hemodialysis
2. previous vitrectomy
3. intraocular surgeries including retinal photocoagulations within 3 months at the time of enrollment
4. high myopia
5. intraocluar pressure of >24 mmHg
6. visual impairment with any causes other than diabetic macular edema
7. uncontrolled hypertension
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Imaizumi |
Organization
Sappro City General Hospial
Division name
Department of Ophthalmology
Zip code
060-8604
Address
1-1, North 11, West 13, Sapporo, 060-8604, Japan
TEL
+81-11-726-2211
hiroko.imaizumi@doc.city.sapporo.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Kinoshita |
Organization
Sappro City General Hospial
Division name
Department of Ophthalmology
Zip code
060-8604
Address
1-1, North 11, West 13, Sapporo, 060-8604, Japan
TEL
+81-11-726-2211
Homepage URL
knst129@gmail.com
Sponsor or person
Institute
Sappro City General Hospial
Institute
Department
Personal name
Funding Source
Organization
Sappro City General Hospial
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
Sappro City General Hospial
Address
1-1, North 11, West 13, Sapporo, 060-8604, Japan
Tel
81 11 826 2211
masatoshi.moria@city.sapporo.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
市立札幌病院眼科、徳島大学大学院医歯薬研究部眼科学分野
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 10 | 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
200
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
Main results already published
Date of protocol fixation
| 2017 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 07 | Day |
Last modified on
| 2020 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029726
