UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001790 |
|---|---|
| Receipt number | R000002156 |
| Scientific Title | Topical dexamethasone aqueous solution for macular edema |
| Date of disclosure of the study information | 2009/03/25 |
| Last modified on | 2019/04/02 07:22:58 |
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Basic information
Public title
Topical dexamethasone aqueous solution for macular edema
Acronym
Topical dexamethasone aqueous solution for macular edema
Scientific Title
Topical dexamethasone aqueous solution for macular edema
Scientific Title:Acronym
Topical dexamethasone aqueous solution for macular edema
Region
| Japan |
Condition
Condition
macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the efficacy of topical cyclodextrin-dexamethansone solution for macular edema
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity, macular thickness
Key secondary outcomes
IOP, adrenal function, blood sugar
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
cyclodextrin dexamethasone eye drops (pilot study)
Interventions/Control_2
cyclodextrin dexamethasone eye drops
Interventions/Control_3
Triamcinolone acetonide sub-Tenon injection
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Macular edema subsequent to diabetic retinopathy, retinal vein occlusion, and uveitis.
Key exclusion criteria
The patients who do not agree with participation to the study.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Tanito |
Organization
Shimane University Faculty of Medicine
Division name
Ophthalmology
Zip code
6938501
Address
Enya 89-1, Izumo
TEL
0853202284
tanito-oph@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Tanito |
Organization
Shimane University Faculty of Medicine
Division name
Ophthalmology
Zip code
6938501
Address
89-1 Tenjin, Izumo
TEL
0853202284
Homepage URL
tanito-oph@umin.ac.jp
Sponsor or person
Institute
Departmet of Ophthalmology, Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Shimane University faculty of Medicine
Address
89-1 Tenjin, Izumo
Tel
0853-20-2111
kodama@jn.shimane-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
| 2009 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
https://www.med.shimane-u.ac.jp/ophthalmology/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.med.shimane-u.ac.jp/ophthalmology/
Number of participants that the trial has enrolled
0
Results
NA
Results date posted
| 2019 | Year | 04 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
NA
Adverse events
NA
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2009 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | Month | 23 | Day |
Last modified on
| 2019 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002156
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
