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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024587
Receipt No. R000028230
Scientific Title Study to examine the efficacy of modified treat and extend regimen of aflibercept to branch retinal vein occlusion with cystoid macular edema
Date of disclosure of the study information 2016/10/27
Last modified on 2020/10/29

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Basic information
Public title Study to examine the efficacy of modified treat and extend regimen of aflibercept to branch retinal vein occlusion with cystoid macular edema
Acronym Modified treat and extend regimen of aflibercept to branch retinal vein occlusion with cystoid macular edema
Scientific Title Study to examine the efficacy of modified treat and extend regimen of aflibercept to branch retinal vein occlusion with cystoid macular edema
Scientific Title:Acronym Modified treat and extend regimen of aflibercept to branch retinal vein occlusion with cystoid macular edema
Region
Japan

Condition
Condition branch retinal vein occlusion
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of aflibercept with modified treat and extend regimen to visual acuity, number of doses and visits number of times in patients with branch retinal vein occlusion with cystoid macular edema.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual acuity and central macular thickness at month 12 after initial injection of aflibercept
Key secondary outcomes Visual acuity and central macular thickness at month 24 after initial injection of aflibercept

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 Two years of modified treat and extend (1 month) of Aflibercept 2 mg
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
89 years-old >=
Gender Male and Female
Key inclusion criteria Patient of branch retinal vein occlusion with cystoid macular edema
Onset within 1 year
Hope of treatment
Willingness to provide written informed consent
Key exclusion criteria Target eye: Prior treatment with anti-VEGF drug and steroid drug
Prior treatment with intraocular surgery (<3 months)
Another diseases to decrease visual acuity
Prior treatment with vitrectomy
Fellow eye is already enrolled in the study (If already both eyes onset, the eye which has wider occlusion area is enrolled.)
Prior history of brain cardiovascular evebts
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 Hidenori
Middle name
Last name Takahashi
Organization Jichi Medical University
Division name Department of Ophthalmology
Zip code 329-0431
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
TEL 0285-58-7382
Email takahah-tky@umin.ac.jp

Public contact
Name of contact person
1st name Hidenori
Middle name
Last name Takahashi
Organization Jichi Medical University
Division name Department of Ophthalmology
Zip code 329-0431
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
TEL 0285-58-7382
Homepage URL
Email takahah-tky@umin.ac.jp

Sponsor
Institute Jichi Medical 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 Aoki Eye Clinic, Okubo Eye Clinic, Saito Eye Clinic, Takahashi Eye Clinic, JCHO Tokyo Shinjuku Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Jichi Medical University
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan
Tel 0285-58-7550
Email rinri@jichi.ac.jp

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 自治医科大学附属病院(栃木県)、青木眼科医院(栃木県)、おおくぼ眼科(栃木県)、斎藤眼科医院(栃木県)、たかはし眼科(栃木県)、JCHO東京新宿メディカルセンター(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 27 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
2016 Year 10 Month 24 Day
Date of IRB
2016 Year 11 Month 07 Day
Anticipated trial start date
2016 Year 10 Month 27 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 27 Day
Last modified on
2020 Year 10 Month 29 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028230

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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