Unique ID issued by UMIN | UMIN000001432 |
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Receipt number | R000001708 |
Scientific Title | Evaluation of difluprednate ophthalmic emulsionfor macular edema and neovascular desease |
Date of disclosure of the study information | 2010/09/30 |
Last modified on | 2021/03/20 10:54:00 |
Evaluation of difluprednate ophthalmic emulsionfor macular edema and neovascular desease
Evaluation of difluprednate ophthalmic emulsionfor macular edema and neovascular desease
Evaluation of difluprednate ophthalmic emulsionfor macular edema and neovascular desease
Evaluation of difluprednate ophthalmic emulsionfor macular edema and neovascular desease
Japan |
macular edema, neovascular eye desease
Ophthalmology |
Others
NO
Evaluation of efficacy and safety of Durezol for macular edema and neovascular desease.
Safety,Efficacy
Foveal thickness
Visual acuity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Difluprednate ophthalmic emulsion is instilled 4 times a day for the first month and then twice a day for 2 months.
20 | years-old | <= |
90 | years-old | > |
Male and Female
The patients with diabetic macular edema and with mean foveal thickness more than 300 micro meter.
The patients with intraocular pressure more than 21 mmHg.
Patients diagnosed as steroid responder.
130
1st name | |
Middle name | |
Last name | Hidetoshi Yamashita |
Yamagata University,Faculty of Medicine
Depertment of Ophthalmology
2-2-2 iida-nishi,Yamagata
023-628-5374
1st name | |
Middle name | |
Last name |
Yamagata University,Faculty of Medicine
Depertment of Ophthalmology
023-628-5374
Yamagata University,Faculty of Medicine
Yamagata University,Faculty of Medicine
NO
2010 | Year | 09 | Month | 30 | Day |
Partially published
84
Mean retinal thickness decreased significantly in patients who completed difluprednate ophthalmic emulsion instillation, and retinal thickness decreased by 20% or more in 37% of cases. No serious complications were observed.
2021 | Year | 03 | Month | 20 | Day |
This trial included 69 eyes of 48 cases in men, 49 eyes of 36 cases in women.The mean age was 63.3 years, and all patients had diabetic macular edema.The mean logMAR visual acuity before instillation in all eyes was 0.39, and the mean foveal retinal thickness was 474.7 um.The severity of diabetic retinopathy was 6 eyes for moderate non-proliferative diabetic retinopathy, 56 eyes for severe non-proliferative diabetic retinopathy, 46 eyes for proliferative diabetic retinopathy. Panretinal photocoagulation was performed in 90 eyes.There were 62 phakic eyes and 56 pseudophakic eyes at baseline. 34 eyes had a history
In 94 eyes of 66 cases completed the eye drop treatment specified in the protocol. After the start of instillation, 24 eyes of 18 cases were discontinued, and most of the reasons were increased intraocular pressure (16 eyes in 12 cases).
The number of cases did not reach the originally planned number.
Intraocular pressure increased to 25 mmHg or more during Durezol instillation in 24 of 118 eyes, but all cases decreased to 21 mmHg or less after discontinuation of Durezol instillation or instillation of intraocular pressure lowering drug.
There was no onset of infection in all eyes.
visual acuity, retinal thickness
none
Completed
2008 | Year | 10 | Month | 15 | Day |
2008 | Year | 09 | Month | 22 | Day |
2008 | Year | 11 | Month | 01 | Day |
2020 | Year | 10 | Month | 01 | Day |
2021 | Year | 03 | Month | 31 | Day |
2008 | Year | 10 | Month | 16 | Day |
2021 | Year | 03 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001708
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