UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010312 |
|---|---|
| Receipt number | R000012069 |
| Scientific Title | Evaluation of the efficacy and safety of intravitreal bimonthly injection of aflibercept for age-related macular degeneration |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2017/12/27 16:07:15 |
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Basic information
Public title
Evaluation of the efficacy and safety of intravitreal bimonthly injection of aflibercept for age-related macular degeneration
Acronym
Bimonthly injection of aflibercept for age-related macular degeneration
Scientific Title
Evaluation of the efficacy and safety of intravitreal bimonthly injection of aflibercept for age-related macular degeneration
Scientific Title:Acronym
Bimonthly injection of aflibercept for age-related macular degeneration
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 and safety with the change of the frequency of the intravitreal injection of afliberdept
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Variation on a logarithm of the minimum angle of resolution 12 months after the first intravitreal injection
Key secondary outcomes
Variation on a central retinal thickness and the number of injection of medicine 12 months after the first intravitreal injection
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
Duration:12 months
Quantity:aflibercept 2mg
Bimonthly injection
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
Patients with active age-related macular degeneration
Key exclusion criteria
Patients with not active age-related macular degeneration,
severe glaucoma, inflammation disease, diabetic retinopathy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahito Ohji |
Organization
Shiga University of Medical Science
Division name
Department of Ophthalmology
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN 520-2192
TEL
0775462276
ohji@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Sawada |
Organization
Shiga University of Medical Science
Division name
Department of Ophthalmology
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN 520-2192
TEL
0775462276
Homepage URL
tsawada@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
滋賀医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2013 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 24 | Day |
Last modified on
| 2017 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012069
