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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010862
Receipt No. 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

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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
Email 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
Email otsuji@takii.kmu.ac.jp

Sponsor
Institute Kansai medical university takii hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012716

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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