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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001790
Receipt No. 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

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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
Email 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
Email tanito-oph@umin.ac.jp

Sponsor
Institute Departmet of Ophthalmology, Shimane University Faculty of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002156

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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