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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026118
Receipt No. 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

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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
Email 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
Email y37373m@yahoo.co.jp

Sponsor
Institute Nayoro city general hospital ophthalmology section
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030014

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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