UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Reduced fluence photodynamic therapy combined with intravitreal anti-vascular endothelial growth factor antibody for age-related macular degeneration.
Title of the study (Brief title)	RFPDT combined with anti-VEGF antibody for AMD.
Region	Japan

Condition
Condition	Age-related macular degeneration
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess outcome for patients with AMD treated with RFPDT combined with anti-VEGF.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	vision acuity, disapearment of neovascularization.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Medicine
Interventions/Control_1	RFPDT anti-VEGFantibody
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	120 years-old >
Gender	Male and Female
Key inclusion criteria	Finding choroidal vascular abnormalities with AMD, and vision loss.
Key exclusion criteria	the patient without exudative changes in fundus.
Target sample size	50

Research contact person
Name of lead principal investigator	Hidetoshi Yamashita
Organization	Yamagata University faculty of Medicine
Division name	Department of Ophthalmology
Address	2-2-2 Iidanishi Yamagata
TEL	023-628-5374
Email	hyama-tky@umin.ac.jp

Public contact
Name of contact person	Shion Hayashi
Organization	Yamagata University faculty of Medicine
Division name	Department of Ophthalmology
Address	2-2-2 iidanishi Yamagata
TEL	+81-23-628-5374
Homepage URL
Email	shion_haneda055@hotmail.com

Sponsor
Institute	Yamagata University Faculty of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Yamagata University Faculty of Medicine
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2010 Year 11 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 04 Month 01 Day
Anticipated trial start date	2009 Year 04 Month 01 Day
Last follow-up date	2011 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 11 Month 15 Day
Last modified on	2016 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005451