UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026118 |
|---|---|
| Receipt number | R000030014 |
| Scientific Title | Short-term effects of intravitreal ranibizumab therapy on diabetic macular edema |
| Date of disclosure of the study information | 2017/02/13 |
| Last modified on | 2017/02/13 22:25:30 |
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Basic information
Public title
Short-term effects of intravitreal ranibizumab therapy on diabetic macular edema
Acronym
Short-term effects of intravitreal ranibizumab therapy on diabetic macular edema
Scientific Title
Short-term effects of intravitreal ranibizumab therapy on diabetic macular edema
Scientific Title:Acronym
Short-term effects of intravitreal ranibizumab therapy on diabetic macular edema
Region
| Japan |
Condition
Condition
diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the short-term effects of intravitreal ranibizumab on diabetic macular edema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The Foveal thickness at 2hours, 1day, 1week and 1month after intravitreal ranibizumab injection.
Key secondary outcomes
The visual acuity at 1day, 1week and 1month after intravitreal ranibizumab injection.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intravitreal ranibizumab injection 0.5 mg/0.05 mL
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were the presence of DME before therapy (foveal thickness at baseline was thicker than 300 microns) and no history of ocular surgery (including laser) and/or other treatment for macular edema within the previous 10 weeks.
Key exclusion criteria
The exclusion criteria were the logarithm of the minimum angle of resolution (logMAR) VA below 0 (20/200, Snellen equivalent).
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiro Minami |
Organization
nayoro city general hospital
Division name
medical examination section
Zip code
Address
nishi 8 minami 7-1 nayoro hokkaido japan
TEL
0165433101
y37373m@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiro Minami |
Organization
Nayoro city general hospital
Division name
medical examination section
Zip code
Address
nishi 8 minami 7-1 nayoro hokkaido japan
TEL
0165433101
Homepage URL
y37373m@yahoo.co.jp
Sponsor or person
Institute
Nayoro city general hospital ophthalmology section
Institute
Department
Personal name
Funding Source
Organization
Nayoro city general hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
名寄市立総合病院/Nayoro city general hospital
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 13 | 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
The mean FT decreased significantly at 2 hours after intravitreal ranibizumab injection. The mean logarithm of the minimum angle of resolution visual acuity improved significantly after 1 month.
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
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
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 | 13 | Day |
Last modified on
| 2017 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030014
| 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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