UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019028 |
|---|---|
| Receipt number | R000022008 |
| Scientific Title | Evaluation of the efficacy, safety and injection interval of intravitreal injection of aflibercept for age-related macular degeneration |
| Date of disclosure of the study information | 2015/09/15 |
| Last modified on | 2023/09/26 14:55:29 |
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Basic information
Public title
Evaluation of the efficacy, safety and injection interval of intravitreal injection of aflibercept for age-related macular degeneration
Acronym
Trimonthly intravitreal injection of aflibercept for age-related macular
degeneration
Scientific Title
Evaluation of the efficacy, safety and injection interval of intravitreal injection of aflibercept for age-related macular degeneration
Scientific Title:Acronym
Trimonthly intravitreal 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
Evaluation of the efficacy, safety and injection interval of intravitreal injection of aflibercept for age-related macular degeneration
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
change in best-corrected visual acuity (BCVA) from baseline to every visits
change in central retinal thickness from baseline to every visits
Key secondary outcomes
rate of adverse events
change on fluorescein angiography
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 2.0mg/0.05mL
Trimonthly 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
Outpatients of Shiga University of Medical Science Hospital with age-related macular degeneration
Patients underwent a full ocular examination, including fluorescein angiography
Key exclusion criteria
severe renal disease
unstable angina
malignant arrhythmia
history of brain infarction
history of cerebral hemorrhage
severe hypertension
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 520-2192, JAPAN
TEL
077-548-2276
ohji@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Ito |
Organization
Shiga University of Medical Science
Division name
Department of Ophthalmology
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga 520-2192, JAPAN
TEL
077-548-2276
Homepage URL
yukaito@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
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（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 15 | 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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 20 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 20 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 20 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 15 | Day |
Last modified on
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022008
