UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022406 |
|---|---|
| Receipt number | R000025822 |
| Scientific Title | Efficacy Verification of Photodynamic Therapy for Serous Pigment Epithelial Detachment without Choroidal Neovascularization |
| Date of disclosure of the study information | 2016/05/23 |
| Last modified on | 2020/11/25 09:29:09 |
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Basic information
Public title
Efficacy Verification of Photodynamic Therapy for Serous Pigment Epithelial Detachment without Choroidal Neovascularization
Acronym
Photodynamic Therapy for Pigment Epithelial Detachment
Scientific Title
Efficacy Verification of Photodynamic Therapy for Serous Pigment Epithelial Detachment without Choroidal Neovascularization
Scientific Title:Acronym
Photodynamic Therapy for Pigment Epithelial Detachment
Region
| Japan |
Condition
Condition
Pigment Epithelial Detachment
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify cure rate, improvement rate, improvement factor, and safety of photodynamic therapy for serous pigment epithelial detachment without choroidal neovascularization.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of disappearance of serous pigment epithelial detachment 3 months and 2 years after treatments
Key secondary outcomes
visual acuity, height of pigment epithelial detachment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Serous pigment epithelial detachment without choroidal neovascularization
Central choroidal thickness >= 300 um
Desiring the treatment
Key exclusion criteria
History of photodynamic therapy
Intraocular surgery within 3 months
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Takahashi |
Organization
Jichi Medical University
Division name
Ophthalmology
Zip code
329-0431
Address
3311-1 Yakushiji Shimotsuke-shi Tochigi
TEL
+81285587382
takahah-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Takahashi |
Organization
Jichi Medical University
Division name
Ophthalmology
Zip code
329-0431
Address
3311-1 Yakushiji Shimotsuke-shi Tochigi
TEL
+81285587382
Homepage URL
takahah-tky@umin.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan
Tel
0285-58-7550
rinri@jichi.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At Jichi Medical University serous pigment detachment without choroidal neovascularization will receive photodynamic therapy. Photodynamic therapy is to adjust the light-sensitive substance verteporfin to 2 mg / mL, diluted with 1.5 mL / m2 as day stations glucose injection to become a 30mL the (body surface area) as the total amount (5%), over 10 minutes administered intravenously, it is irradiated laser beam to 15 minutes after administration of this drug beginning [wavelength 689 +- 3nm, light irradiation amount of energy 50J / cm2 (83 seconds at an irradiation output 600mW / cm2)] to the treatment spot. Irradiation diameter is greatest linear diameter +1 mm within 7 mm. The optic nerve head should be avoided. The gender, age, pre-treatment and awareness, optical coherence tomography images of the vision, the fundus photos and distortion after treatment for one month, three months, one year, two years extracted from the medical records, the cure rate and the visual acuity improvement and fovea calculate the thinning of the retina thickness and the center choroid thickness, to verify whether pre-treatment visual acuity, retinal thickness, choroidal thickness, sex, and age is related to the degree of healing. If there is a way complications described it. There is no increase the inspection and visit by participating in this study.
Management information
Registered date
| 2016 | Year | 05 | Month | 23 | Day |
Last modified on
| 2020 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025822
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