Unique ID issued by UMIN | UMIN000002770 |
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Receipt number | R000003211 |
Scientific Title | Photodynamic therapy with two third dose verteporfin for central serous chorioretinopathy:Prospective intervention trial |
Date of disclosure of the study information | 2009/11/17 |
Last modified on | 2016/05/17 11:51:13 |
Photodynamic therapy with two third dose verteporfin for central serous chorioretinopathy:Prospective intervention trial
Photodynamic therapy with two third dose verteporfin for central serous chorioretinopathy
Photodynamic therapy with two third dose verteporfin for central serous chorioretinopathy:Prospective intervention trial
Photodynamic therapy with two third dose verteporfin for central serous chorioretinopathy
Japan |
Central serous chorioretinopathy
Ophthalmology |
Others
NO
To compare the efficacy and safety of two third dose verteporfin photodynamic therapy(PDT) with half dose for central serous chorioretinopathy.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II,III
resolution of serous retinal detachment of 4 days, 1 month, 3 months, 6 months, and 1 year after PDT
1)visual acuity
2)thickness of retina and serous retinal detachment at fovea on optical coherence tomography
3)choroidal thickness on optical coherence tomography
4)amplitudes and implicit time of a-wave, b-wave and odcillatory potentials recorded by focal macula electroretinogram
5)visual field
6)fluorescein angiography
7)indocyanine green angiography
time of assessment
1)-5) : 4 days, 1 month, 3 months, 6 months, and 1 year after PDT
6),7) : 1 month, 3 months, and 1 year after PDT
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Maneuver |
4mg/m2 intravenous infusion of verteporfin over 10 minutes followed by delivery of laser at 15 minutes.
Nonthermal laser light of 689nm wavelength is applied for 83 sec delivering a dose of 50J/cm2 at a light intensity of 0.6W/cm2.
20 | years-old | <= |
70 | years-old | >= |
Male and Female
1. 3 months or more after onset
2. presence of active angiographic leakage under or adjacent to fovea
in fluorescein angiography
3. presence of serous retinal detachment(SRD) on optical coherence tomography(OCT)
4. written informed consent
5. re-treatment is considered to the patients with recurrent or persistent SRD on OCT
1. drug allery to verteporfin
2. pregnant or expecting pregnancy
3. porphyria, or hypersensitivity to artificial illumination
4. macular diseases other than CSC
5. others (inappropriate case judged by investigator or subinvestigators)
6
1st name | |
Middle name | |
Last name | Yasuki Ito |
Nagoya University School of Medicine
Department of Ophthalmology
Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
052-741-2111
yasu@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Ruka Maruko |
Nagoya University School of Medicine
Department of Ophthalmology
Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
052-741-2111
rutia@xg8.so-net.ne.jp
Nagoya University School of Medicine Department of Ophthalmology
None
Self funding
NO
名古屋大学医学部附属病院(愛知県)
2009 | Year | 11 | Month | 17 | Day |
Unpublished
Completed
2009 | Year | 11 | Month | 16 | Day |
2009 | Year | 11 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2009 | Year | 11 | Month | 17 | Day |
2016 | Year | 05 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003211
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