UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002128 |
|---|---|
| Receipt number | R000002600 |
| Scientific Title | Anti-VEGF combined with Verteporfin photodynamic therapy in age-related macular degeneration(AMD) |
| Date of disclosure of the study information | 2009/06/29 |
| Last modified on | 2019/01/04 14:03:12 |
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Basic information
Public title
Anti-VEGF combined with Verteporfin photodynamic therapy in age-related macular degeneration(AMD)
Acronym
Conbination therapy for AMD
Scientific Title
Anti-VEGF combined with Verteporfin photodynamic therapy in age-related macular degeneration(AMD)
Scientific Title:Acronym
Conbination therapy 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 evaluate the efficacy of anit-VEGF therapy combined with photodynamic therapy in AMD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
visual acuity, fundus examination including FA, IA and optical coherence tomography(OCT).
Key secondary outcomes
general examination of ocular findings
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
cases with age-related macular degeneration
Key exclusion criteria
subjects with systemic risk factors
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Yamashita |
Organization
Yamagata University Hospital
Division name
Department of Ophthalmolgy
Zip code
Address
Iidanishi2-2-2, yamagata
TEL
023-628-5374
shionhaneda055@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Yamashita |
Organization
Yamagata University Hospital
Division name
Department of Ophthalmolgy
Zip code
Address
Iidanishi2-2-2, yamagata
TEL
023-628-5374
Homepage URL
shionhaneda055@gmail.com
Sponsor or person
Institute
Yamagata University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yamagata University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 06 | Month | 29 | 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
Completed
Date of protocol fixation
| 2007 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 04 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 04 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 04 | Day |
Other
Other related information
Mauclar thickness from baseline significantly changed in combined therapy group compared with single treatment group.
Management information
Registered date
| 2009 | Year | 06 | Month | 27 | Day |
Last modified on
| 2019 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002600
