UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023676 |
|---|---|
| Receipt number | R000027268 |
| Scientific Title | Intravitreal anti-VEGF therapies for macular edema folowing age-related macular degeneration |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2023/07/28 11:07:01 |
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Basic information
Public title
Intravitreal anti-VEGF therapies for macular edema folowing age-related macular degeneration
Acronym
Intravitreal anti-VEGF therapy for AMD
Scientific Title
Intravitreal anti-VEGF therapies for macular edema folowing age-related macular degeneration
Scientific Title:Acronym
Intravitreal anti-VEGF 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 determine outcomes of patients with anti-vasucular endthelial factor antibody-treated age-related macular degeneration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity
Key secondary outcomes
intraocular pressure, central retinal thickness, subfoveal choroidal thickness, nAMD subtype, drusen subtype, recurrence of macular edema, smoking history, medical history (high blood pressure, diabetes, cerebral infarction, myocardial infarction), Plasma catecholamines level
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patinets with age-related macular degeneration
Key exclusion criteria
none
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kamao |
Organization
Kawasaki Medical School
Division name
Department of Ophthalmology
Zip code
701-0114
Address
Kurashiki
TEL
086-462-1111
hironeri@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kamao |
Organization
Kawasaki Medical School
Division name
Department of Ophthalmology
Zip code
701-0114
Address
Kurashiki
TEL
086-462-1111
Homepage URL
https://m.kawasaki-m.ac.jp/kenkyu/rinri/kadai/kadai40.php
hironeri@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki Medical School
Address
Kurashiki Matsushima 577
Tel
086-462-1111
hironeri@med.kawasaki-m.ac.jp
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
| 2016 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study, non-intervention, non-invasive
Management information
Registered date
| 2016 | Year | 08 | Month | 18 | Day |
Last modified on
| 2023 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027268
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/07/05 | 研究実施計画書.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2017/07/05 | AMD 症例データ仕様書.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/02/27 | Low data.xlsx |
