UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041469 |
|---|---|
| Receipt number | R000046706 |
| Scientific Title | Comparison of 5-year treatment result of laser photocoagulation and intravitreal injection of bevacizumab for retinopathy of prematurity |
| Date of disclosure of the study information | 2020/08/21 |
| Last modified on | 2022/03/23 16:41:41 |
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Basic information
Public title
Comparison of 5-year treatment result of laser photocoagulation and intravitreal injection of bevacizumab for retinopathy of prematurity
Acronym
Treatment result of intravitreal injection of bevacizumab for retinopathy of prematurity
Scientific Title
Comparison of 5-year treatment result of laser photocoagulation and intravitreal injection of bevacizumab for retinopathy of prematurity
Scientific Title:Acronym
Treatment result of intravitreal injection of bevacizumab for retinopathy of prematurity
Region
| Japan |
Condition
Condition
Retinopathy of prematurity
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the treatment results and safety at the age of 5 between the laser group and the intravitreal injection of bevacizumab group.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity at the age of 5
Key secondary outcomes
Equivalent spherical value, ocular complications and mental retardation at the age of 5
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
| Not applicable |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent laser photocoagulation or intravitreal injection of bevacizumab for retinopathy of prematurity.
Key exclusion criteria
Patients who did not have at least 5 years of follow-up.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshimi |
| Middle name | |
| Last name | Sugiura |
Organization
University of Tsukuba
Division name
Department of ophthalmology
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL
029-853-3148
yoshimis@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Murakami |
Organization
University of Tsukuba
Division name
Department of ophthalmology
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL
029-853-3148
Homepage URL
murakami-tuk@umin.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba Clinical Research and Development Organization
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
029-853-3914
t-credo.adm@un.tsukuba.ac.jp
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
| 2020 | Year | 08 | Month | 21 | 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
Main results already published
Date of protocol fixation
| 2020 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 03 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 05 | Day |
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2020 | Year | 08 | Month | 20 | Day |
Last modified on
| 2022 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046706
