UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014929 |
|---|---|
| Receipt number | R000017372 |
| Scientific Title | The efficacy of topical NSAIDs for anti-VEGF therapy for vitreomacular disease |
| Date of disclosure of the study information | 2014/08/23 |
| Last modified on | 2018/01/14 16:24:20 |
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Basic information
Public title
The efficacy of topical NSAIDs for anti-VEGF therapy for vitreomacular disease
Acronym
The efficacy of topical NSAID
Scientific Title
The efficacy of topical NSAIDs for anti-VEGF therapy for vitreomacular disease
Scientific Title:Acronym
The efficacy of topical NSAID
Region
| Japan |
Condition
Condition
retinal vein occlusion
diabetic retinopathy
age related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of topical NSAID for anti-VEGF treatment in vitreomacular disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression of visual acuity
Regression of macular thickness
Key secondary outcomes
frequecy of anti-VEGF treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Topical NSAID for 1 year follow up
Interventions/Control_2
Topical artificial tear as placebo for 1 year follow up
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 diabetic retinopathy, retinal vein occlusion, or age-related macular degeneration.
central macular thickness more than 400 mirometer.
logMAR visual acuity between 0.5 and 1
treatment naive case
senseitive to anti-VEGF therapy
Key exclusion criteria
macular ischemia
ocular inflammation
systemic disorder other than hypertension and hypercholesterolaemia
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Shimura |
Organization
Tokyo Medical University Hachioji Medical center
Division name
Department of Ophthalmology
Zip code
Address
1163 Tate-machi, Hachioji Tokyo
TEL
0426655611
masahiko@v101.vaio.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanako Yasuda |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Ophthalmology
Zip code
Address
1163 Tate-machi, Hachioji Tokyo
TEL
0426655611
Homepage URL
kana6723@yahoo.co.jp
Sponsor or person
Institute
NTT East japan Tohoku Hospital
Institute
Department
Personal name
Funding Source
Organization
NTT East japan Tohoku Hospital
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
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
ＮＴＴ東日本東北病院（宮城県）
東京医科大学八王子医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/27306783
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
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 23 | Day |
Last modified on
| 2018 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017372
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
