Unique ID issued by UMIN | UMIN000012549 |
---|---|
Receipt number | R000014677 |
Scientific Title | Combination Treatment of Intravitreal Ranibizumab, focal/Grid Laser and panretinal photocoagulation in patients with diabetic macular edema |
Date of disclosure of the study information | 2014/03/01 |
Last modified on | 2014/04/21 17:50:34 |
Combination Treatment of Intravitreal Ranibizumab, focal/Grid Laser and panretinal photocoagulation in patients with diabetic macular edema
Combination treatment of intravitreal Ranibizumab and photocoagulation in patients with diabetic macula edema
Combination Treatment of Intravitreal Ranibizumab, focal/Grid Laser and panretinal photocoagulation in patients with diabetic macular edema
Combination treatment of intravitreal Ranibizumab and photocoagulation in patients with diabetic macula edema
Japan |
diabetic macula edema
Ophthalmology |
Others
NO
To evaluate the mean gain in BCVA and the number of intravitreal ranibizumab injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation.
Safety,Efficacy
visual acuity improvement, central macula thickness, number of intravitreal renibizumab injections
intra ocular pressure, plasma levels of vascular endothelial growth factor(VEGF), aqueous concentrations of various cytokines, blood pressure
Single arm
Randomized
Single blind -investigator(s) and assessor(s) are blinded
Active
1
Treatment
Medicine |
intravitreal ranibizumab injections
retinal photocoagulation
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1)stable medication for the management of diabetes within 3 months
2)visual impairment due to focal or diffuse DME
3)decreased vision due to DME and not other causes
1)concomitant conditions in the study eye that could prevent the improvement in VA on the study
2)active intraocular inflammation or infection in either eye
3)uncontrolled glaucoma in either eye
4)treatment with antiangiogenic drugs in the study eye within 3 months before randomization
5)history of stroke and systolic blood pressure>160mmHg or diastolic BP>100mmHg,untreated hypertension, or change in antihypertensive treatment within 3 months preceding baseline.
40
1st name | |
Middle name | |
Last name | Murata Toshinori |
Shinshu university school of medicine
Department of Ophthalmology
3-1-1 Asahi, Matsumoto, Nagano
+81-263-37-2664
murata@sshinshu-u.ac.jp
1st name | |
Middle name | |
Last name | Takao Hirano |
Shinshu university school of medicine
Department of Ophthalmology
3-1-1 Asahi, Matsumoto, Nagano
+81-263-37-2664
takaoh@shinshu-u.ac.jp
Shinshu university school of medicine
Department of Ophthalmology
Novartis Pharma K.K.
Profit organization
NO
信州大学附属病院(長野県)
2014 | Year | 03 | Month | 01 | Day |
Unpublished
Open public recruiting
2014 | Year | 03 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2013 | Year | 12 | Month | 11 | Day |
2014 | Year | 04 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014677