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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | UMIN000026033 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | diabetic retinopathy | |
Classification by specialty |
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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 |
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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 | |||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Sappro City General Hospial |
Institute | |
Department |
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 |
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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 | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Main results already published | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029726 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |