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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007566
Receipt No. R000008707
Scientific Title Photocoagulation for peripheral areas of nonperfusion to prevent the recurrence of diabetic macular edema after intravitreal injection of bevacizumab.
Date of disclosure of the study information 2012/04/15
Last modified on 2015/01/05

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Basic information
Public title Photocoagulation for peripheral areas of nonperfusion to prevent the recurrence of diabetic macular edema after intravitreal injection of bevacizumab.
Acronym Peripheral photocoagulation to prevent the recurrence of diabetic macular edema after bevacizumab-injection .
Scientific Title Photocoagulation for peripheral areas of nonperfusion to prevent the recurrence of diabetic macular edema after intravitreal injection of bevacizumab.
Scientific Title:Acronym Peripheral photocoagulation to prevent the recurrence of diabetic macular edema after bevacizumab-injection .
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 photocoagulation for peripheral areas of non-perfusion to prevent the recurrence of diabetic macular edema after intravitreal injection of bevacizumab .
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Best corrected visual acuity at 6 months after the injection of bevacizumab.
Key secondary outcomes Central retinal thickness at 6 months after the injection of bevacizumab.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Photocoagulation for peripheral areas of non-perfusion after injection of bevacizumab.
Interventions/Control_2 Injection of bevacizumab without photocoagulation.
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
35 years-old <
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Diabetic patients with macular edema more than 300 micro and hard exdates.

Patient who obtained agreement after enough explanation when participating in this study is received.
Key exclusion criteria History of ocular surgery, Ocular diseases except for diabetic macular edema.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Takamura
Organization Faculty of Medical Sciences, University of Fukui
Division name Department of Ophthalmology
Zip code
Address 23-3 Matsuoka, Eiheiji, Yoshida, Fukui, Japan.
TEL 0776-61-8403
Email ytakamura@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Takamura
Organization Faculty of Medical Sciences, University of Fukui
Division name Department of Ophthalmology
Zip code
Address 23-3 Matsuoka, Eiheiji, Yoshida, Fukui, Japan.
TEL 0776-61-8403
Homepage URL
Email ytakamura@hotmail.com

Sponsor
Institute Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui
Institute
Department

Funding Source
Organization None
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
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
2012 Year 04 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2012 Year 03 Month 21 Day
Date of IRB
Anticipated trial start date
2012 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
2012 Year 03 Month 24 Day
Last modified on
2015 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008707

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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