Unique ID issued by UMIN | UMIN000002229 |
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Receipt number | R000002731 |
Scientific Title | Photodynamic therapy with half dose verteporfin for central serous chorioretinopathy:Prospective intervention trial |
Date of disclosure of the study information | 2009/07/20 |
Last modified on | 2014/05/17 17:00:17 |
Photodynamic therapy with half dose verteporfin for central serous chorioretinopathy:Prospective intervention trial
Photodynamic therapy with half dose verteporfin for central serous chorioretinopathy
Photodynamic therapy with half dose verteporfin for central serous chorioretinopathy:Prospective intervention trial
Photodynamic therapy with half dose verteporfin for central serous chorioretinopathy
Japan |
Central serous chorioretinopathy
Ophthalmology |
Others
NO
To evaluate the efficacy and safety of half dose verteporfin photodynamic therapy(PDT) for central serous chorioretinopathy.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II,III
resolution of serous retinal detachment of 4 days, 1 month, 3 months and 1 year after PDT
1)visual acuity
2)optical coherence tomography
3)amplitudes and implicit time of a-wave, b-wave and odcillatory potentials recorded by focal macula electroretinogram
4)visual field
5)fluorescein angiography
6)indocyanine green angiography
time of assessment
1)-5) : 4 days, 1 month, 3 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
Uncontrolled
1
Treatment
Medicine | Maneuver |
3mg/m2 intravenous infusion of verteporfin over 10 minutes followed by delivery of diode laser at 689nm 15 minutes after the start of the infusion.
Light dose rate is 600 mW/cm2, time of photosensitization is 83 seconds, and total light energy is 50J/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)
10
1st name | |
Middle name | |
Last name | Hiroko Terasaki |
Nagoya University School of Medicine
Department of Ophthalmology
Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
052-741-2111
terasaki@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
052-744-2277
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 | 07 | Month | 20 | Day |
Partially published
Completed
2009 | Year | 06 | Month | 15 | Day |
2009 | Year | 06 | Month | 01 | Day |
2011 | Year | 01 | Month | 01 | Day |
2011 | Year | 01 | Month | 01 | Day |
2011 | Year | 01 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2009 | Year | 07 | Month | 20 | Day |
2014 | Year | 05 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002731
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