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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035829
Receipt No. R000040816
Scientific Title The effect of intravitreal injection of ranibizumab before direct photocoagulation in the treatment of focal diabetic macular edema
Date of disclosure of the study information 2019/02/13
Last modified on 2019/02/10

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Basic information
Public title The effect of intravitreal injection of ranibizumab before direct photocoagulation in the treatment of focal diabetic macular edema
Acronym Ranibizumab treatment with lasers for focal DME
Scientific Title The effect of intravitreal injection of ranibizumab before direct photocoagulation in the treatment of focal diabetic macular edema
Scientific Title:Acronym Ranibizumab treatment with lasers for focal DME
Region
Japan

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

Objectives
Narrative objectives1 To investigate the effect of intravitreal injection of ranibizumab for the treatment of diabetic 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 THe frequency of additional treatment

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients with type 1 or type 2 diabetes mellitus 20 years of age or older.
Patients with fovea involving diabetic macular edema (judged with central subfield thickness on OCT).
Patients with reduced visual acuity associated with diabetic macular edema.
Patients with a central retinal thickness (CRT) of 300 um or more on the OCT retinal map (measured in mm) as an objective finding.
Patients who are willing and able to visit the study site, as scheduled, and undergo scheduled examinations in this study
Patients who can provide written voluntary consent to participate in this study after receiving adequate explanation.
Key exclusion criteria A history of any intraocular surgery in the study eye within the previous 90 days
It is considered difficult to improve visual acuity due to morphological changes
Glaucoma with poor IOP control, a history of glaucoma filtering surgery, or scheduled filtering surgery in the study eye
IOP of the study eye: more than 25 mmHg
Myopia of -8D or greater
Optic media in which it is difficult to obtain fundus photographs or OCT images
Severe systemic infections at baseline
Systemic anticoagulation therapy within 180
Poorly controlled diabetes mellitus
Poorly controlled hypertension
A history of cerebrovascular accident and/or myocardial infarction within 180 days
Patients on dialysis and patients with renal failure requiring dialysis
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Takamura
Organization University of Fukui
Division name Ophthalmology
Zip code
Address 23-3 Shimoaizuki Matsuoka Yoshida Fukui
TEL 0776618403
Email takamurayoshihiro@gmail.com

Public contact
1st name of contact person
1st name
Middle name
Last name Yoshihiro Takamura
Organization University of Fukui
Division name Ophthalmology
Zip code
Address 23-3 Shimoaizuki Matsuoka Yoshida Fukui
TEL 0776618403
Homepage URL
Email takamurayoshihiro@gmail.com

Sponsor
Institute University of Fukui, Ophthalmology
Institute
Department

Funding Source
Organization University of Fukui, Ophthalmology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization 2

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
2019 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
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 Open public recruiting
Date of protocol fixation
2015 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 02 Month 10 Day
Last modified on
2019 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040816

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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