UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011656 |
|---|---|
| Receipt number | R000013632 |
| Scientific Title | Posterior subtenon injection of triamcinolone acetonide reduces the use of intravitreal bevacizumab for diffuse diabetic macular edema |
| Date of disclosure of the study information | 2013/09/05 |
| Last modified on | 2016/12/31 21:09:10 |
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Basic information
Public title
Posterior subtenon injection of triamcinolone acetonide reduces the use of intravitreal bevacizumab for diffuse diabetic macular edema
Acronym
Combination therapy for DDME
Scientific Title
Posterior subtenon injection of triamcinolone acetonide reduces the use of intravitreal bevacizumab for diffuse diabetic macular edema
Scientific Title:Acronym
Combination therapy for DDME
Region
| Japan |
Condition
Condition
Diffuse Diabetic Macular Edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of posterior subtenon injections of triamcinolone acetonide during treatment with intravitreal injections of bevacizumab in eyes with diffuse diabetic macular edema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Foveal thickness were monitored monthly for 1-year. The total number of intravitreal injections of bevacizumab injections during the follow-up
Key secondary outcomes
logMAR visual acuity and intraocular pressure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Initially, both eyes of each patient received 1.25mg/0.05ml of intravitreal injection of bevacizumab. One eye then received 20mg/0.5ml of subtenon injection of triamcinolone acetonide at the onset, and at 16, 32 and 48 weeks. The other eye acted as the control eye and was not treated with subtenon injection of triamcinolone acetonide
Interventions/Control_2
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
Type II diabetic patients whose bilateral DDME with foveal thickness greater than 400 micrometer and with logMAR visual acuity worse than 0.3
Key exclusion criteria
Eyes with severe proliferative retinopathy were excluded from the study. Patients with a history of focal or pan retinal photocoagulation and/or cataract surgery in either eye within the 6 months prior to entry into the study, and patients who had previous therapies for DDME, including grid laser treatment, intravitreal injection of any drugs, and/or vitreous surgery, were excluded from this study. Patients with systemic disorders other than hypertension and hypercholesterolemia were excluded from this study.
Target sample size
10
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
090-2274-8107
masahiko@v101.vaio.ne.jp
Public contact
Name of contact person
| 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
090-2274-8107
Homepage URL
masahiko@v101.vaio.ne.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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 05 | 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
Subtenon triamcinolone acetonide (STTA)-treated eyes, as compared to their controls, had significantly more regression of foveal thickness (FT) and improvement of visual acuity (VA) at several time points during the study. The required number of intravitreal injection of bevcizumab (IVB) injections in STTA-treated eyes during the study was 5.00 plus-minus 1.75, which was significantly less than 7.95 plus-minus 1.57 in the control eyes.
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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 05 | Day |
Last modified on
| 2016 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013632
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
