UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011091 |
|---|---|
| Receipt number | R000012989 |
| Scientific Title | Investigation of clinical efficacy for Aflibercept in patients with polypoidal choroidal vasculopathy (PCV) |
| Date of disclosure of the study information | 2013/07/02 |
| Last modified on | 2021/03/17 22:09:36 |
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Basic information
Public title
Investigation of clinical efficacy for Aflibercept in patients with polypoidal choroidal vasculopathy (PCV)
Acronym
Investigation of Eylea for PCV
Scientific Title
Investigation of clinical efficacy for Aflibercept in patients with polypoidal choroidal vasculopathy (PCV)
Scientific Title:Acronym
Investigation of Eylea for PCV
Region
| Japan |
Condition
Condition
Polypoidal Choroidal Vasculopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of aflibercept on best-collected visual acuity in patients with PCV by 3 injections for loading phase and then bimonthly injections
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of improved/maintained visual acuity at month 12
Key secondary outcomes
Change of BCVA (best-collected visual acuity), central macular thickness and subretinal fluid on OCT (optical coherence tomography), disease area on fluorescent angiography (FA), regression of polyp on indocyanine green angiography (ICGA)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
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) Written informed consent
2) wAMD on FA, ICGA and OCT
3) PCV on fundus photography and ICGA
4) Treatment-naïve PCV
5) BCVA>0.05
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 dexamethasone (<6 months) or triamcinolone (<30 days), intraocular surgery (<3 months)
4) Active intraocular inflammation
5) Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products
6) pregnant women and nursing mothers
7) Patient who the doctor in charge judges are ineligible for the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuro Ishibshi |
Organization
Graduate School of Medical Sciences,
Kyushu University
Division name
Department of Ophthalmology
Zip code
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Oshima |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
yuji@eye.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Graduate School of Medical Sciences,
Kyushu 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
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
| 2013 | Year | 07 | Month | 02 | 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
| 2013 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 02 | Day |
Last modified on
| 2021 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012989
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
