UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000432
Receipt No. R000000523
Scientific Title A randomized controlled trial of triamcinolone intravitreal injection versus vitrectomy for diabetic macular edema.
Date of disclosure of the study information 2006/06/21
Last modified on 2008/02/12

* 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 A randomized controlled trial of triamcinolone intravitreal injection versus vitrectomy for diabetic macular edema.
Acronym A trial of triamcinolone intravitreal injection versus vitrectomy for diabetic macular edema.
Scientific Title A randomized controlled trial of triamcinolone intravitreal injection versus vitrectomy for diabetic macular edema.
Scientific Title:Acronym A trial of triamcinolone intravitreal injection versus vitrectomy for diabetic macular edema.
Region
Japan

Condition
Condition Patients with diabetic macula edema.
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of treatment with diabetic macular edema.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Foveal thickness using optical coherent tomography
Key secondary outcomes Best correlate visual acuity

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 4 mg triamcinolone intravitreal injection
Interventions/Control_2 vitrectomy
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Patients with type 2 diabetes mellitus
(2)HbA1c less than 10%
(3)Foveal thickness more than 300 micron m on OCT3000
(4)Visual acuity of 0.3-1.0 logMAR
Key exclusion criteria Exclusion criteria were: (1)active proliferatve diabetic retinopathy: (2) previous vitreoretinal surgery; (3) treatment of laser photocoagulation within 3 months; (4) other treatments for diabetic macular edema within 3months; (5) a history of glaucoma and ocular hypertention
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taiji Sakamoto
Organization Faculty of medicine, Kagoshima university graduate school of medicine and dental sciences
Division name Department of ophthalmology,
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima
TEL 099-275-5402
Email

Public contact
Name of contact person
1st name
Middle name
Last name Norihito Doi
Organization Faculty of medicine, Kagoshima university graduate school of medicine and dental sciences
Division name Department of ophthalmology
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima
TEL 099-275-5402
Homepage URL
Email doi@m3.kufm.kagoshima-u.ac.jp

Sponsor
Institute Faculty of medicine, Kagoshima university graduate school of medicine and dental sciences
Institute
Department

Funding Source
Organization Faculty of medicine, Kagoshima university graduate school of medicine and dental sciences
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 06 Month 21 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
Date of protocol fixation
2006 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2006 Year 06 Month 01 Day
Last follow-up date
2009 Year 06 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
2006 Year 06 Month 20 Day
Last modified on
2008 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000523

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.