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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023590
Receipt No. 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

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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
Email 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
Email machidas@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University, Koshigaya Hospital
Department of Ophthalmology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026913

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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