UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Long-term results of the modified photodynamic therapy (PDT) procedure for exudative age-related macular degeneration (AMD) patients with difficulties in PDT
Title of the study (Brief title)	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	Tsuyoshi Otsuji
Organization	Kansai medical university takii hospital
Division name	Department of ophthalmology
Address	10-15 Fumizono-cho Moriguchi, Osaka
TEL	06-6992-1001
Email	otsuji@takii.kmu.ac.jp

Public contact
Name of contact person	Tsuyoshi Otsuji
Organization	Kansai medical university takii hospital
Division name	Department of ophthalmology
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000012716