Unique ID issued by UMIN | UMIN000009854 |
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Receipt number | R000011544 |
Scientific Title | Randomized controlled clinical trials on the therapeutic effects of triamcinolone acetonide versus bevacizumab for diabetic macular edema |
Date of disclosure of the study information | 2013/01/25 |
Last modified on | 2023/01/15 18:22:37 |
Randomized controlled clinical trials on the therapeutic effects of triamcinolone acetonide versus bevacizumab for diabetic macular edema
Randomized controlled clinical trials on the therapeutic effects of triamcinolone acetonide versus bevacizumab for diabetic macular edema
Randomized controlled clinical trials on the therapeutic effects of triamcinolone acetonide versus bevacizumab for diabetic macular edema
Randomized controlled clinical trials on the therapeutic effects of triamcinolone acetonide versus bevacizumab for diabetic macular edema
Japan |
diabetic macular edema
Ophthalmology |
Others
NO
To compare the effect of improving the visual acuity and central retinal thickness with intravitreal injection of triamcinolone acetonide or bevacizumab for diabetic macular edema.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
visual acuity
Foveal thickness and subfoveal choroidal thickness using optical coherent tomography
Frequency of recurrence
Complications
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
Pseudo-randomization
2
Treatment
Medicine |
Intravitreal injection of triamcinolone acetonide and follow up at least 6 months.
Intravitreal injection of bevacizumab and follow up at least 6 months.
18 | years-old | <= |
Not applicable |
Male and Female
Aged 18 years or older.
Diffuse DME(CMT 300microns < determined by OCT).
Visual acuity: 1.0 logMAR >
Eyes with active proliferative DR.
Eyes with known a history of glaucoma,optic nerve atrophy.
History of laser photocoagulation within 3 months
History of intravitreal injection or subrenon injection for diabetic macular edema within 3months.
Aphakia
Patients with any of serious heart disease, cerebrovascular disease,blood disorder, renal failure, malignant tumor, systemic steroids.
Cases clear OCT images can not be obtained
Patients with known as steroid responder.
80
1st name | |
Middle name | |
Last name | Taiji Sakamoto |
Kagoshima University Graduate School of Medical and Dental Science
Department of Ophthalmology
Sakuragaoka 8-35-1, Kagoshima, 890-8520 Japan
099-275-5402
shou@m3.kufm.kagoshima-u.ac.jp
1st name | |
Middle name | |
Last name | Shozo Sonoda |
Kagoshima University Graduate School of Medical and Dental Science
Department of Ophthalmology
Sakuragaoka 8-35-1, Kagoshima, 890-8520 Japan
099-275-5402
shou@m3.kufm.kagoshima-u.ac.jp
Kagoshima University Graduate School of Medical and Dental Science
none
Self funding
NO
鹿児島大学病院(鹿児島県)
2013 | Year | 01 | Month | 25 | Day |
Unpublished
Completed
2012 | Year | 10 | Month | 01 | Day |
2012 | Year | 10 | Month | 01 | Day |
2012 | Year | 10 | Month | 01 | Day |
2015 | Year | 10 | Month | 01 | Day |
2013 | Year | 01 | Month | 23 | Day |
2023 | Year | 01 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011544
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