UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037679 |
|---|---|
| Receipt number | R000042969 |
| Scientific Title | Effects of glaucoma on the therapeutic effects of anti-vascular endothelial growth factor agents on macular edema associated with retinal vein branch occlusion |
| Date of disclosure of the study information | 2019/08/13 |
| Last modified on | 2019/08/13 20:37:48 |
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Basic information
Public title
Effects of glaucoma on the therapeutic effects of anti-vascular endothelial growth factor agents on macular edema associated with retinal vein branch occlusion
Acronym
Effects of glaucoma on on macular edema associated with retinal vein branch occlusion
Scientific Title
Effects of glaucoma on the therapeutic effects of anti-vascular endothelial growth factor agents on macular edema associated with retinal vein branch occlusion
Scientific Title:Acronym
Effects of glaucoma on on macular edema associated with retinal vein branch occlusion
Region
| Japan |
Condition
Condition
macular edema associated with retinal vein branch occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of glaucoma on the therapeutic effects of anti-vascular endothelial growth factor inhibitors on macular edema associated with retinal vein branch occlusion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of central retina thicknes
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Visual disturbance due to center involved ME(evaluated using OCT)treated with anti-VEGF agents
2)BCVA(pre-treatment) is over 24 letters(20/320)
3)CRT>300 micro meter
4)Over 12 month followup after treatment.
Key exclusion criteria
1)Ocular diseases other than BRVO-ME
2)Severe general complications
3)Those who inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Sugimoto |
Organization
Mie University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
0592315027
sugmochi@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | Sugimoto |
| Last name | Sugimoto |
Organization
Mie University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
0592315027
Homepage URL
sugmochi@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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 Graduate School of Medicine
Address
2-174 Edobashi, Tsu, Mie, Japan
Tel
0592315027
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
| 2019 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
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 | 08 | Month | 13 | Day |
Last modified on
| 2019 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042969
