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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000455
Receipt No. R000000553
Scientific Title A randomized controlled trial on therapeutic effects of sub-Tenon's capsule injection of triamcinolone acetonide in prevention of occurrence and inhibition of progression of diabetic macular edema caused by panretinal photocoagulation
Date of disclosure of the study information 2006/07/27
Last modified on 2009/01/27

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Basic information
Public title A randomized controlled trial on therapeutic effects of sub-Tenon's capsule injection of triamcinolone acetonide in prevention of occurrence and inhibition of progression of diabetic macular edema caused by panretinal photocoagulation
Acronym A randomized controlled trial on therapeutic effects of sub-Tenon's capsule injection of triamcinolone acetonide in prevention of occurrence and inhibition of progression of diabetic macular edema caused by panretinal photocoagulation
Scientific Title A randomized controlled trial on therapeutic effects of sub-Tenon's capsule injection of triamcinolone acetonide in prevention of occurrence and inhibition of progression of diabetic macular edema caused by panretinal photocoagulation
Scientific Title:Acronym A randomized controlled trial on therapeutic effects of sub-Tenon's capsule injection of triamcinolone acetonide in prevention of occurrence and inhibition of progression of diabetic macular edema caused by panretinal photocoagulation
Region
Japan

Condition
Condition diabetic retinopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this trial is to evaluate the safety and efficacy of sub-Tenon's capsule injection of triamcinolone acetonide in the prevention of occurrence and the inhibition of progression of diabetic macular edema caused by panretinal photocoagulation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Best-corrected visual acuity (logarithm of the minimum angle of resolution) at 6 months after treatment
Key secondary outcomes Best-corrected visual acuity (logMAR) at 1,3 months after treatment
Foveal thickness at 1week, 1,3,6 months after treatment
Intraocular pressure at 1,3,6 months after treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A single sub-Tenon's injection of triamcinolone acetonide (20mg) and panretinal photocoagulation
Interventions/Control_2 Panretinal photocoagulation
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 severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy, whose retinopathy is bilateral and symmetrical, and panretinal ptotocoagulation is required for.
Key exclusion criteria (1)Intraocular pressure is more than 21 mmHg
(2)Massive cataract
(3)Ocular pathology other than diabetic retinopathy (e.g., glaucoma, age-related macular degeneration)
(4)Tractional retinal detachment or massive proliferation
(5)Vitreous hemorrhage
(6)Unilateral or asymmetrical diabetic retinopathy
(7)Neovascular glaucoma
(8)Previous vitreoretinal surgery
(9)Previous panretinal photocoagulation
(10)Pregnant or lactating women
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mihori Kita
Organization Kyoto University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 54 Shogoinkawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL 075-751-3250
Email

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Unoki
Organization Kyoto University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 54 Shogoinkawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL 075-751-3250
Homepage URL
Email noriharu@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine, Department of Ophthalmology
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
Address
Tel
Email

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
2006 Year 07 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

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
2006 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2006 Year 07 Month 01 Day
Last follow-up date
2007 Year 10 Month 01 Day
Date of closure to data entry
2007 Year 11 Month 01 Day
Date trial data considered complete
2007 Year 12 Month 01 Day
Date analysis concluded
2008 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 07 Month 27 Day
Last modified on
2009 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000553

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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