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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011273
Receipt No. R000013212
Scientific Title Effect of aflibercept in wet age-related macular degenaration (wAMD) with retinal pigment epithelium detachment (PED)
Date of disclosure of the study information 2013/07/25
Last modified on 2018/07/30

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Basic information
Public title Effect of aflibercept in wet age-related macular degenaration (wAMD) with retinal pigment epithelium detachment (PED)
Acronym Effect of aflibercept in wAMD with PED
Scientific Title Effect of aflibercept in wet age-related macular degenaration (wAMD) with retinal pigment epithelium detachment (PED)
Scientific Title:Acronym Effect of aflibercept in wAMD with PED
Region
Japan

Condition
Condition exudative age related macular degeneration
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of aflibercept on visual acuity and retinal morphology in AMD with PED
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Ratio of patients with improved/maintained BCVA at month 12
2) Ratio of patients with PED regression
Key secondary outcomes Change of BCVA, PED, central macular thickness, polyp lesion, etc.

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 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) Willingness to provide written informed consent
2) wAMD with CNV on FA, ICGA, OCT
3) PED (>1 disc diameter) on OCT
4) Treatment na&iuml;ve
5) BCVA > 0.1 (decimal score)
Key exclusion criteria 1) Drusenoid PED
2) Avascular PED
3) GLD of the total lesion area > 12
4) Presence of RPE tears or macular hole
5) Subretinal hemorrhage, scar or macular fibrosis (>50% lesion area)
5) History of Triamcinolone (< 6 months), dexamethasone (< 30 days), intraocular surgery (< 6 months)
6) Vitrectomy, submacular surgery, etc.
7) Active intraocular inflammation
8) Hypersensitivity or allergy to fluorescein, indocyanine green, etc.
9) Pregnancy, lactating woman
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kanji Takahashi
Organization Kansai Medical University
Division name Department of Ophthalmology
Zip code
Address Shinmachi 2-5-1, Hirakata
TEL 072-804-0101
Email nagaiy@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimi Nagai
Organization Kansai Medical University
Division name Department of Ophthalmology
Zip code
Address Shinmachi 2-5-1, Hirakata
TEL 072-804-0101
Homepage URL
Email nagaiy@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

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
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 関西医科大学附属病院、関西医科大学附属滝井病院、大阪大学医学部附属病院、住友病院

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 25 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 Terminated
Date of protocol fixation
2013 Year 07 Month 11 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2015 Year 06 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
2013 Year 07 Month 25 Day
Last modified on
2018 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013212

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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