UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014946 |
|---|---|
| Receipt number | R000015409 |
| Scientific Title | Evaluation of optimum timing for intravitreal injection of aflibercept for age-related macular degeneration |
| Date of disclosure of the study information | 2016/07/07 |
| Last modified on | 2017/03/25 22:09:35 |
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Basic information
Public title
Evaluation of optimum timing for intravitreal injection of aflibercept for age-related macular degeneration
Acronym
Evaluation of optimum timing for intravitreal injection of aflibercept for age-related macular degeneration
Scientific Title
Evaluation of optimum timing for intravitreal injection of aflibercept for age-related macular degeneration
Scientific Title:Acronym
Evaluation of optimum timing for intravitreal injection of aflibercept for age-related macular degeneration
Region
| Japan |
Condition
Condition
Wet age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the visual outcome of treat and extend regimen(TAE) in managing wet age-related macular degeneration with intravitreal aflibercept.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of eyes at week 52 that maintained best-corrected visual acuity (BCVA; lost <15 letters from baseline); change from baseline in BCVA.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravitreal aflibercept with traet and extend regimen
Interventions/Control_2
Intravitreal aflibercept every 8 weeks
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
Patient with new-onset, active, subfoveal, choroidal neovascularization lesions (or juxtafoveal with leakage affecting the fovea) secondary to age-related macular degeneration
Key exclusion criteria
Presence of other causes of CNV, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye.
History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye.
Active intraocular inflammation in the study eye.
Active ocular or periocular infection in study eye.
Uncontrolled glaucoma in the study eye.
Prior treatment with anti VEGF therapy in the study eye.
History of myocardial infarction or stroke in the past 3 months.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenobu Tanihara |
Organization
Faculty of life sciences, Kumamoto university
Division name
Department of ophthalmology
Zip code
Address
1-1-1,honjyo,chuo-ku,kumamoto,kumamoto,japan
TEL
096-344-2111
ganka@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuya Inomata |
Organization
Faculty of life sciences, Kumamoto university
Division name
Department of ophthalmology
Zip code
Address
1-1-1,honjyo,chuo-ku,kumamoto,kumamo
TEL
096-344-2111
Homepage URL
inoyas@kxb.biglobe.ne.jp
Sponsor or person
Institute
Faculty of life sciences, Kumamoto university
Institute
Department
Personal name
Funding Source
Organization
Faculty of life sciences, Kumamoto university
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
熊本大学医学部附属病院（熊本県）、出田眼科医院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 07 | 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
| 2014 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 25 | Day |
Last modified on
| 2017 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015409
