UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of Ranibizumab for diabetes macular edema
Acronym	Evaluation of Ranibizumab for diabetes macular edema
Scientific Title	Evaluation of Ranibizumab for diabetes macular edema
Scientific Title:Acronym	Evaluation of Ranibizumab for diabetes macular edema
Region	Japan

Condition
Condition	diabetes macular edema
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of efficacy and safety of Ranibizumab for diabetes macular edema.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	retinal thickness, visual acuity
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intravitreal injection of Ranibizumab
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	The patients with diabetic macular edema.
Key exclusion criteria	Tha patients who has history of myocardial infarction and brain infarction.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hidetoshi Yamashita
Organization	Yamagata University faculty of medicine
Division name	Department of ophthalmology
Zip code
Address	2-2-2 iida-nishi ,yamagata city
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Sakiko Nakano
Organization	Yamagata University faculty of medicine
Division name	Department of ophthalmology
Zip code
Address	2-2-2 iida-nishi,Yamagata city
TEL	023-628-5374
Homepage URL
Email

Sponsor
Institute	Yamagata University faculty of Medecine,department of ophthalmology
Institute
Department

Funding Source
Organization	Yamagata University Faculty of Medicine
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information	2010 Year 10 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	Terminated
Date of protocol fixation	2009 Year 05 Month 01 Day
Date of IRB	2009 Year 05 Month 01 Day
Anticipated trial start date	2009 Year 05 Month 01 Day
Last follow-up date	2020 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 05 Month 19 Day
Last modified on	2021 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002393