UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023590 |
|---|---|
| Receipt number | R000026913 |
| Scientific Title | The Change of focal macular electroretinogram(ERG) in patients with age-related macular degeneration after intravitreal aflibercept(IVA). |
| Date of disclosure of the study information | 2016/08/15 |
| Last modified on | 2016/08/10 18:53:33 |
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Basic information
Public title
The Change of focal macular electroretinogram(ERG) in patients with age-related macular degeneration after intravitreal aflibercept(IVA).
Acronym
Focal macular ERG with wAMD sfter IVA.
Scientific Title
The Change of focal macular electroretinogram(ERG) in patients with age-related macular degeneration after intravitreal aflibercept(IVA).
Scientific Title:Acronym
Focal macular ERG with wAMD sfter IVA.
Region
| Japan |
Condition
Condition
Age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary study objective is to investigate effect of aflibercept on visual acuity and focal macular ERG of japanese wAMD patients at 12M.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
The change of the amplitude of the focal macular ERG at the 12 month from baseline.
Key secondary outcomes
1. Change of BCVA at the 12 month.
2. Change of the amplitude of the focal macular ERG at the 3,6 and 12 month.
3. Change of the retinal thickness evaluated by SD-OCT at the 12 month.
4. Correlation between the focal macular ERG amplitude and BCVA.
5. Correlation between the focal macular ERG amplitude and retinal thickness.
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) BCVA:0.1-1.0
2) naive AMD with subfoveal fluid on fluorescent angiography, indocyanine green angiography and/or optical coherence tomography
3) Willingness to provide written informed consent
4) outpatients
Key exclusion criteria
1) Patients with any previous history of treatment of other retinal diseases with pharmacologic agents including verteporfin photodynamic therapy, aflibercept, ranibizumab, bevacizumab or steroids.
2) Clinically significant drug allergy.
3) History of vitrectomy or glaucoma surgery.
4) Presence of RPE tears, angoid streaks or pathologic myopia.
5) Concomitant conditions/diseases including uncontrolled glaucoma and intraocular inflammation
6) Patients 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 | Shigeki Machida |
Organization
Dokkyo Medical University, Koshigaya Hospital
Division name
Department of Ophthalmology
Zip code
Address
2-1-50, Minami-koshigaya, Koshigaya city, Saitama, Japan
TEL
048-965-1111
machidas@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeki Machida |
Organization
Dokkyo Medical University, Koshigaya Hospital
Division name
Department of Ophthalmology
Zip code
Address
2-1-50, Minami-koshigaya, Koshigaya city, Saitama, Japan
TEL
048-965-1111
Homepage URL
machidas@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University, Koshigaya Hospital
Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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 | 08 | 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
Date of protocol fixation
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 10 | Day |
Last modified on
| 2016 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026913
