UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016598 |
|---|---|
| Receipt number | R000019263 |
| Scientific Title | Study of visual and anatomical outcomes of second year aflibercept in good visual acuity baseline of wet age-related macular degeneration |
| Date of disclosure of the study information | 2015/02/22 |
| Last modified on | 2023/06/06 09:45:17 |
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Basic information
Public title
Study of visual and anatomical outcomes of second year aflibercept in good visual acuity baseline of wet age-related macular degeneration
Acronym
Study of second year aflibercept in patients with wAMD
Scientific Title
Study of visual and anatomical outcomes of second year aflibercept in good visual acuity baseline of wet age-related macular degeneration
Scientific Title:Acronym
Study of second year aflibercept in patients with wAMD
Region
| Japan |
Condition
Condition
Age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of second year aflibercept with monthly treat and extend regimen in patients with good visual acuity wAMD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of best-collected visual acuity and proportion of improved, maintained and deteriorated visual acuity at month 24 from 12 after initial injection of aflibercept
Key secondary outcomes
Change of (best-collected visual acuity) BCVA, central macular thickness, subretinal fluid and polyps regression
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
Eylea (aflibercept)
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
1) baseline BCVA in the study eye over 0.5 (Decimal VA)
2) AMD with Subfoveal fluid on fluorescent angiography, indocyanine green angiography and/or optical coherence tomography
3) Willingness to provide written informed consent
4) outpatient
5) second year aflibercept treatment
Key exclusion criteria
1) Greatest Linear Dimension (GLD) of the total lesion area <12 Macular Photocoagulation Study Disc Areas
2) Presence of subretinal hemorrhage, scar or macular fibrosis (>50% lesion area)
3) Prior treatment with anti-VEGF drug, photodynamic therapy
4) Prior treatment with dexamethasone (<6 months) or triamcinolone (<30 days), intraocular surgery (<3 months)
5) Active intraocular inflammation
6) Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products
7) Patient who the doctor in charge judges are ineligible for the study
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenori Takahashi |
Organization
Jichi Medical University
Division name
Department of Ophthalmology
Zip code
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
TEL
0285-58-7382
takahah-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenori Takahashi |
Organization
Jichi Medical University
Division name
Department of Ophthalmology
Zip code
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
TEL
0285-58-7382
Homepage URL
takahah-tky@umin.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
JCHO Tokyo Shinjuku Medical Center
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
| 2015 | Year | 02 | Month | 22 | Day |
Related information
URL releasing protocol
https://doi.org/10.2147/OPTH.S160961
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.2147/OPTH.S160961
Number of participants that the trial has enrolled
39
Results
Intravitreal aflibercept for exudative age-related macular degeneration with good visual acuity: 2-year results of a prospective study.
Shinichi Sakamoto, Hidenori Takahashi, Yuji Inoue, Yusuke Arai, Satoru Inoda, Natsuko Kakinuma, Yujiro Fujino, Tatsuro Tanabe, Hidetoshi Kawashima, Yasuo Yanagi
Clinical ophthalmology (Auckland, N.Z.) 12 1137-1147 2018
Results date posted
| 2023 | Year | 06 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
　Japanese Age-related Macular Degeneration
Participant flow
Recruited at each facility for 2 years of regular medical care
Adverse events
None
Outcome measures
Visual Acuity and Central Subfield Thickness
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 22 | Day |
Last modified on
| 2023 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019263
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