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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031718
Receipt No. R000036226
Scientific Title Study of Treat and Extend Regimen using Aflbercept for macular edema (CRVO-ME) associated with central retinal vein occlusion
Date of disclosure of the study information 2018/03/14
Last modified on 2018/03/14

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Basic information
Public title Study of Treat and Extend Regimen using Aflbercept for macular edema (CRVO-ME) associated with central retinal vein occlusion
Acronym Investigation of TAE Regimen of Aflibercept for CRVO-ME
Scientific Title Study of Treat and Extend Regimen using Aflbercept for macular edema (CRVO-ME) associated with central retinal vein occlusion
Scientific Title:Acronym Investigation of TAE Regimen of Aflibercept for CRVO-ME
Region
Japan

Condition
Condition Central retinal vein occlusion with macular edema
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the effectiveness and safety of Aflbercept intravitreal injection by Treat and Extend Regimen for patients with macular edema associated with central venous occlusion.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Average change in best corrected visual acuity (BCVA) at week 24 from baseline.
Key secondary outcomes 1. Average change in BCVA from baseline to week 52.
2. Average change of Center Retinal Thickness by Optical Coherence Tomography (OCT) from baseline to week 24 and 52.
3. Comparison and change of foveal avascular zone (FAZ), Vascular Density in each layers by OCT Angiography (OCTA) at week 24 and 52.
4. Evaluation of avascular field (NPA) by fluorescence angiography (FA) examination at Baseline, week 24 and week 52.
5. Change in retina sensitivity by microperimetry (MP-3) from baseline to week 4, week 24, week 52.
6. The average number of Aflibercept administration (times per year) until week 52, and the injection interval until week 52 and at week 52.
7. Change in Quality Of Vision by NEI-VFQ-25 from Baseline to Week 24 and Week 52.

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 intravitreal Aflibercept injection
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 20 years and over
Within 9 months from symptoms (onset) of visual acuity decline
Decreased visual acuity due to macular edema according to central retinal vein occlusion (decimal visual acuity is 0.7 or less)
the consent of this research
Key exclusion criteria 1) Binocular CRVO
2) Glaucoma with poor control (intraocular pressure > 24 mmHg)
3) High blood pressure with poor control
4) Decreased visual acuity due to non-CRVO-ME in the target eye (age-related macular degeneration, diabetic macular edema, diabetic retinopathy, macular forebrain, atrophy of the macula)
5) iris neovascularization, vitreous hemorrhage, traction retinal detachment in the target eye
6) Topical steroid administration within the past 180 days for the target eye
7) Anti-VEGF drug within the past 90 days for the target eye Intravitreal injection
8) Cataract surgery history within the past 90 days for the target eye
9) posterior capsule opening operation within the past 30 days for the target eye
10) All intraocular surgical history within the past 90 days for the target eye
11) Pan-retinal photocoagulation in the target eye
12) Intermediate translucers difficult to obtain fundus photographs and OCT images in the target eyes
13) Administration of systemic angiogenesis inhibitor within 180 days from the scheduled initial dose of Afli Berceptet
14) Cerebrovascular disorder and / or myocardial infarction within 180 days from the scheduled initial dose of Afli Berceptet
15) Renal failure that may require dialysis or dialysis
16) Systemic diseases requiring the administration of drugs that may affect the results of this study
17) Patients with a history of hypersensitivity to the ingredients of this drug
18) Patients infected with eyes or around the eyes, or patients suspected to be infected
19) Patients with severe inflammation in the eye
20) Pregnant women or women who may be pregnant
21) Women who are breastfeeding
22) Patients who wish to have childbirth or do not want contraception during the research period
23) Fluorescein allergy
24) Participation in another trial within 30 days from the scheduled date of Afriveltept's first dose
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinori Murata
Organization Shinshu University
Division name Dept. Ophthalmology
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2664
Email murata@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Imai
Organization Shinshu University
Division name Dept. Ophthalmology
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2664
Homepage URL
Email imai@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
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
2018 Year 03 Month 14 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 14 Day
Last modified on
2018 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036226

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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