UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010862 |
|---|---|
| Receipt number | R000012716 |
| Scientific Title | Long-term results of the modified photodynamic therapy (PDT) procedure for exudative age-related macular degeneration (AMD) patients with difficulties in PDT |
| Date of disclosure of the study information | 2013/06/04 |
| Last modified on | 2017/05/31 11:11:54 |
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Basic information
Public title
Long-term results of the modified photodynamic therapy (PDT) procedure for exudative age-related macular degeneration (AMD) patients with difficulties in PDT
Acronym
Modified PDT procedure (ironing PDT) for exudative AMD patients with difficulties in PDT
Scientific Title
Long-term results of the modified photodynamic therapy (PDT) procedure for exudative age-related macular degeneration (AMD) patients with difficulties in PDT
Scientific Title:Acronym
Modified PDT procedure (ironing PDT) for exudative AMD patients with difficulties in PDT
Region
| Japan |
Condition
Condition
Exudative age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For exudative age-related macular degeneration, photodynamic therapy (PDT) is sometimes impossible to cover a large lesion. We investigate the long-term efficacy of the modified PDT procedure for those cases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigation of the efficacy of Ironing PDT by visual acuity and optical coherence tomographic findings to 24 months after the treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Perform PDT by moving the PDT laser spot at a constant speed for 83 seconds to cover the whole lesion.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Exudative AMD with the lesion that is not covered by the ordinary use of PDT either because the lesion is too large or too close to the optic nerve disc.
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Otsuji |
Organization
Kansai medical university takii hospital
Division name
Department of ophthalmology
Zip code
Address
10-15 Fumizono-cho Moriguchi, Osaka
TEL
06-6992-1001
otsuji@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Otsuji |
Organization
Kansai medical university takii hospital
Division name
Department of ophthalmology
Zip code
Address
10-15 Fumizono-cho Moriguchi, Osaka
TEL
06-6992-1001
Homepage URL
otsuji@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai medical university takii hospital
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
関西医科大学附属滝井病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 03 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 10 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 03 | Day |
Last modified on
| 2017 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012716
| 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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| Registered date | File name |
