UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012094 |
|---|---|
| Receipt number | R000014132 |
| Scientific Title | Vitreous injection of anti vascular endothelium growth factor for macular edema. |
| Date of disclosure of the study information | 2013/10/30 |
| Last modified on | 2023/08/16 23:51:54 |
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Basic information
Public title
Vitreous injection of anti vascular endothelium growth factor for macular edema.
Acronym
VEGF injection for macular edema
Scientific Title
Vitreous injection of anti vascular endothelium growth factor for macular edema.
Scientific Title:Acronym
VEGF injection for macular edema
Region
| Japan |
Condition
Condition
macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine usefulness of TER method for macular edema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity, intraocular pressure, anterior&posterior eye examination, visual function and morphology of retina.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Anti-VEGF addiministration using TER method.
Interventions/Control_2
Anti-VEGF addiministration using PRN method.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Macular edema with diabetes, retinal vein occulusion and uveites, those who obtained informed concent.
Key exclusion criteria
Those who under 20 years old, determined that not appropriatable by doctor and pregnant women.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Sugimoto |
Organization
Mie University Schoolof Medicine
Division name
Department of Ophthalmology
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie, Japan, 514-8507
TEL
059-231-5027
sugmochi@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Sugimoto |
Organization
Mie University Schoolof Medicine
Division name
Department of Ophthalmology
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie, Japan, 514-8507
TEL
059-232-1111
Homepage URL
sugmochi@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Schoolof Medicine
Institute
Department
Personal name
Funding Source
Organization
Mie University Schoolof Medicine
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
Mie University Schoolof Medicine
Address
2-174, Edobashi, Tsu, Mie, Japan
Tel
059-232-1111
sugmochi@clin.medic.mie-u.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
| 2013 | Year | 10 | Month | 30 | 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
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 21 | Day |
Last modified on
| 2023 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014132
