UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008816 |
|---|---|
| Receipt number | R000008553 |
| Scientific Title | The study of the amount of laser irradiation in photodynamic therapy for exudative age-related macular degeneration |
| Date of disclosure of the study information | 2012/09/10 |
| Last modified on | 2014/10/06 07:15:23 |
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Basic information
Public title
The study of the amount of laser irradiation in photodynamic therapy for exudative age-related macular degeneration
Acronym
The study of the amount of laser irradiation in photodynamic therapy
Scientific Title
The study of the amount of laser irradiation in photodynamic therapy for exudative age-related macular degeneration
Scientific Title:Acronym
The study of the amount of laser irradiation in photodynamic therapy
Region
| Japan |
Condition
Condition
age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety with the amount of laser irradiation in photodynamic therapy for age-related macular degeneration
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Variation on a logarithm of the minimum angle resolution of 12 months after the initial photodynamic therapy
Key secondary outcomes
To assess complication of 12 months after the initial photodynamic therapy and examine retinal angiography and retinal thickness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Standard-fluence photodynamic therapy
Interventions/Control_2
Reduced-fluence photodynamic therapy
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
treatment naive age-related macular degeneration with subfoveal choroidal neovascularization with visual acuity from 0.1 to 0.5
Key exclusion criteria
choroidal neovascularization secondary to pathological myopia and other disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Mizukawa |
Organization
Kawasaki Medical School Hospital
Division name
Ophthalmology
Zip code
Address
577 Matsshima, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
mizu-p@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Mizukawa |
Organization
Kawasaki Medical School Hospital
Division name
Ophthalmology
Zip code
Address
577 Matsshima, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
Homepage URL
mizu-p@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2012 | Year | 09 | Month | 10 | 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
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
| 2012 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 31 | Day |
Last modified on
| 2014 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008553
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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