UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007566 |
|---|---|
| Receipt number | 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 10:15:13 |
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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
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
ytakamura@hotmail.com
Sponsor or person
Institute
Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008707
