UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013410 |
|---|---|
| Receipt number | R000015649 |
| Scientific Title | Evaluation of efficacy of topical bromfenac (0.1%) as an adjunctive therapy for patients with retinal vein occlusion |
| Date of disclosure of the study information | 2014/03/14 |
| Last modified on | 2023/07/05 14:38:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of efficacy of topical bromfenac (0.1%) as an adjunctive therapy for patients with retinal vein occlusion
Acronym
Efficacy of topical bromfenac for retinal vein occlusion
Scientific Title
Evaluation of efficacy of topical bromfenac (0.1%) as an adjunctive therapy for patients with retinal vein occlusion
Scientific Title:Acronym
Efficacy of topical bromfenac for retinal vein occlusion
Region
| Japan |
Condition
Condition
retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of topical bromfenac (0.1%) as an adjunctive therapy to anti-VEGF therapy for patients with retinal vein occlusion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
total number of injections of ranibizumab during 12 months' follow-up
Key secondary outcomes
Variation on a central retinal thickness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
topical bromfenac as an adjunctive therapy to intravitreal injection of ranibizumab
Interventions/Control_2
topical artificail tears as the sham of blomfenac to intravitreal injection of ranibizumab
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
Outpatients of Shiga University of Medical Science Hospital with retinal vein occlusion that are examined by angiography or checked retinal thickness.
Key exclusion criteria
severe renal disease
unstable angina
malignant arrhythmia
history of brain infarction
history of cerebral hemorrhage
severe hypertension
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahito Ohji |
Organization
Shiga University of Medical Science
Division name
Department of Ophthalmology
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga 520-2192, JAPAN
TEL
077-548-2276
ohji@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitsugu Saishin |
Organization
Shiga University of Medical Science
Division name
Department of Ophthalmology
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga 520-2192, JAPAN
TEL
077-548-2276
Homepage URL
saishin@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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
滋賀医科大学附属病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 14 | 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
| 2014 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2016 | 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
| 2014 | Year | 03 | Month | 13 | Day |
Last modified on
| 2023 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015649
