Unique ID issued by UMIN | UMIN000020753 |
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Receipt number | R000023948 |
Scientific Title | Efficacy and safety in adequate regimen of anti-vascular endothelial growth factor (VEGF) therapy for patients with diabetic macular edema |
Date of disclosure of the study information | 2016/01/27 |
Last modified on | 2016/01/27 01:44:59 |
Efficacy and safety in adequate regimen of anti-vascular endothelial growth factor (VEGF) therapy for patients with diabetic macular edema
Adequate anti-VEGF therapy for DME
Efficacy and safety in adequate regimen of anti-vascular endothelial growth factor (VEGF) therapy for patients with diabetic macular edema
Adequate anti-VEGF therapy for DME
Japan |
diabetic macular edema
Ophthalmology |
Others
NO
To determine the adequate regimen in ranibizumab intravitreal injection for diabetic macular edema and to evaluate the decrease of number of the injections and the improvement in visual acity
Safety,Efficacy
Change in best-corrected visual acuity from baseline to the time point of the final injection
Proportion of improvement or no change or worsening in change of best-corrected visual acuity from baseline to the time point of final injection
Change in fluorescin angiography and optical coherence tomography (OCT)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Patients with diabetic macular edema receive bi-monthly ranibizumab intravitreal injections.
When the best-corrected visual acuity worsen more than 0.3 log MAR visual acuity one month after each injection, the patients receive ranibizumab injection.
20 | years-old | <= |
Not applicable |
Male and Female
Definite retinal thickening due to diabetic macula edema on clinical examination involving the center of the macula assessed to be the main cause of visual loss.
Best-corrected logMAR visual acuity > 0.22.
Retinal thickness measured on spectral domain optical coherence tomography > 300 micron in the central subfield.
Anti-VEGF therapy within the prior 3 months.
Retinal photocoagulation within the prior 3 months.
Steroid therapy within the prior 3 months.
Major ocular surgery within the prior 3 months.
A myocardial infarction or other cardiac event requiring hospitalization.
cerebrovascular accident, transient ischemic attack, or acute congestive heart failure.
20
1st name | |
Middle name | |
Last name | Osamu Sawada |
Shiga University of Medical Science
Ophtalmology
Seta Tukinowacho, Otsu, Shiga
077-548-2276
osawada@belle.shiga-med.ac.jp
1st name | |
Middle name | |
Last name | Osamu Sawada |
Shiga University of Medical Science
Ophthalmology
Seta Tsukinowacho, Otsu, Shiga
077-548-2276
osawada@belle.shiga-med.ac.jp
Shiga University of Medical Science
Health, Labour and Welfare Ministry
NO
滋賀医科大学医学部附属病院
2016 | Year | 01 | Month | 27 | Day |
Unpublished
Open public recruiting
2014 | Year | 09 | Month | 16 | Day |
2014 | Year | 09 | Month | 30 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 04 | Month | 30 | Day |
2018 | Year | 05 | Month | 30 | Day |
2018 | Year | 06 | Month | 30 | Day |
2016 | Year | 01 | Month | 27 | Day |
2016 | Year | 01 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023948
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