UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028347 |
|---|---|
| Receipt number | R000032450 |
| Scientific Title | Safety and effectiveness of selective retina therapy combined with anti-VEGF therapy for macular edema |
| Date of disclosure of the study information | 2017/09/30 |
| Last modified on | 2020/11/11 11:05:29 |
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Basic information
Public title
Safety and effectiveness of selective retina therapy combined with anti-VEGF therapy for macular edema
Acronym
Safety and effectiveness of SRT combined with anti-VEGF therapy for macular edema
Scientific Title
Safety and effectiveness of selective retina therapy combined with anti-VEGF therapy for macular edema
Scientific Title:Acronym
SRT combined with anti-VEGF therapy for macular edema
Region
| Japan |
Condition
Condition
branch retinal vein occlusion, central retinal vein occlusion, diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the possibility of reducing the number of intravitreal anti-VEGF therapy by combinding SRT for macular edema
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change of central macular thickness at one-year follow up period
Key secondary outcomes
Number of intravitreal anti-VEGF for 1 year follow-up
change of best corrected visual acuity and fluorescein angiography at one-year follow up period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Anti-VEGF alone group
Interventions/Control_2
Combined Anti-VEGF and SRT group
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
patients with macular edema caused subjective symptoms such as central scotoma, metamorphopsia and central visual loss
Key exclusion criteria
ophthalmic exclusion criteria:
patients who had inflammation within the eye
systemic exclusion criteria:
people who had systemic inflammatory disease, hemorrhagic diathesis or anticoagulant therapy, untreated hypertension or diabetes mellitus. peple who is pregnant or at risk of becoming pregnant.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Yamamoto |
Organization
Osaka City University, Graduate School of Medicine, Department of Ophthalmology and Visual sciences
Division name
Ophthalmology
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abenoku, Osaka-shi, Japan
TEL
06-6645-3867
manabun@msic.med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Yamamoto |
Organization
Osaka City University, Graduate School of Medicine, Department of Ophthalmology and Visual sciences
Division name
Ophthalmology
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abenoku, Osaka-shi, Japan
TEL
06-6645-3867
Homepage URL
manabun@msic.med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University, Graduate School of Medicine, Department of Ophthalmology and Visual sciences
Institute
Department
Personal name
Funding Source
Organization
Osaka City University, Graduate School of Medicine, Department of Ophthalmology and Visual sciences
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
Ethical Committee of Osaka City University Graduate School of Medicine
Address
1-2-7, Abeno Medix 6F, Asahi-machi, Abeno-ku, Osaka, Japan
Tel
06-6645-3456
ethics@med.osaka-cu.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
| 2017 | Year | 09 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | 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
| 2017 | Year | 07 | Month | 24 | Day |
Last modified on
| 2020 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032450
