UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024587 |
|---|---|
| Receipt number | 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 | 2023/06/06 09:31:58 |
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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
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
takahah-tky@umin.ac.jp
Sponsor or person
Institute
Jichi Medical University
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
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
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
https://doi.org/10.3390/jcm10143162
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3390/jcm10143162
Number of participants that the trial has enrolled
50
Results
Arai Y, Takahashi H, Inoda S, Sakamoto S, Tan X, Inoue Y, Tominaga S, Kawashima H, Yanagi Y. Efficacy of Modified Treat-and-Extend Aflibercept Regimen for Macular Edema Due to Branch Retinal Vein Occlusion: 1-Year Prospective Study. J Clin Med 2020
Arai Y, Takahashi H, Inoda S, Sakamoto S, Tan X, Inoue Y, Tominaga S, Kawashima H, Yanagi Y. Efficacy of Modified Treat-and-Extend Regimen of Aflibercept for Macular Edema from Branch Retinal Vein Occlusion:2-Year Prospective Study Outcomes. J Clin Med 2021
Results date posted
| 2023 | Year | 06 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Japanese BRVO
Participant flow
Recruited at each facility for 2 years of regular medical care
Adverse events
None
Outcome measures
Visual Acuity and Central Subfield Thickness
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
| 2023 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028230
