UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024419 |
|---|---|
| Receipt number | R000028106 |
| Scientific Title | Long term outcomes of intravitreous aflibercept injections for agerelated macular degeneration |
| Date of disclosure of the study information | 2016/10/15 |
| Last modified on | 2016/10/15 18:27:33 |
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Basic information
Public title
Long term outcomes of intravitreous aflibercept injections for agerelated
macular degeneration
Acronym
Long term outcomes of IAI for AMD
Scientific Title
Long term outcomes of intravitreous aflibercept injections for agerelated
macular degeneration
Scientific Title:Acronym
Long term outcomes of IAI 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 examine the long-term effect of intravitreal aflibercept injection for eyes with age-related macular degeneration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Best corrected visual acuity, retinal structure, choroidal structure, and adverse event.
Key secondary outcomes
Number of IAI.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who diagnosed wet AMD.
Key exclusion criteria
Patients who diagnosed central serous chorioretinopathy CSC or any other vitreo-retinal diseases.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuki Ito |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Ophthalmology Protective care for Sensory Disorders
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya City
TEL
052-744-2275
yasu@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Takayama |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Ophthalmology Protective care for Sensory Disorders
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya City
TEL
052-744-2275
Homepage URL
keitaka1234@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology Protective care for Sensory Disorders, Nagoya University Graduate School of Medicine
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
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
| 2016 | Year | 10 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We compared outcomes of IAI for eyes with
naive wet AMD visiting Nagoya University Hospital, Nagoya city, Japan for the first time between December 2012 to December 2015 and contunuing follow-up treatment were enrolled. The changes of visual acuity, retinal structure, choroidal structure, focal macular electroretinogram, and number of injection were compared.
Management information
Registered date
| 2016 | Year | 10 | Month | 15 | Day |
Last modified on
| 2016 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028106
