UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004562 |
|---|---|
| Receipt number | R000005451 |
| Scientific Title | Reduced fluence photodynamic therapy combined with intravitreal anti-vascular endothelial growth factor antibody for age-related macular degeneration. |
| Date of disclosure of the study information | 2010/11/15 |
| Last modified on | 2016/05/23 13:34:07 |
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Basic information
Public title
Reduced fluence photodynamic therapy combined with intravitreal anti-vascular endothelial growth factor antibody for age-related macular degeneration.
Acronym
RFPDT combined with anti-VEGF antibody for AMD.
Scientific Title
Reduced fluence photodynamic therapy combined with intravitreal anti-vascular endothelial growth factor antibody for age-related macular degeneration.
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Yamashita |
Organization
Yamagata University faculty of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-2-2 Iidanishi Yamagata
TEL
023-628-5374
hyama-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shion Hayashi |
Organization
Yamagata University faculty of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-2-2 iidanishi Yamagata
TEL
+81-23-628-5374
Homepage URL
shion_haneda055@hotmail.com
Sponsor or person
Institute
Yamagata University Faculty of Medicine
Institute
Department
Personal name
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)
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
| 2010 | Year | 11 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005451
