UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014116 |
|---|---|
| Receipt number | R000016430 |
| Scientific Title | Study of effects on the retina morphological changes and vision of Aflibercept intravitreal injection in patients with macular edema due to central retinal vein occlusion. |
| Date of disclosure of the study information | 2014/06/14 |
| Last modified on | 2019/03/15 11:11:33 |
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Basic information
Public title
Study of effects on the retina morphological changes and vision of Aflibercept intravitreal injection in patients with macular edema due to central retinal vein occlusion.
Acronym
Study of effects of Aflibercept in patients with macular edema due to central retinal vein occlusion.
Scientific Title
Study of effects on the retina morphological changes and vision of Aflibercept intravitreal injection in patients with macular edema due to central retinal vein occlusion.
Scientific Title:Acronym
Study of effects of Aflibercept in patients with macular edema due to central retinal vein occlusion.
Region
| Japan |
Condition
Condition
For recurrent or persistent macular edema due to central retinal vein occlusion of the following anti
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aflibercept intravitreal injection, central retinal thickness, foveal choroidal thickness, exudative changes, retinal blood flow to observe the effect on the change
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.The improvement rate of best corrected visual acuity at six months after the Aflibercept injection.
2.Presence or absence of exudative change, the changes of central retinal thickness and foveal choroidal thickness by OCT at 6 and 12 months after the Aflibercept injection.
Key secondary outcomes
1.The retinal blood flow changes measureed by LSFG at 6 and 12 months after the Aflibercept injection.
2.Duration from Aflibercept injection to recurrence.
3.Adverse event
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 administration of Aflibercept(Genetical Recombination)(EYLEA)
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
1.Patients with macular edema due to central retinal vein occlusion.
2.Central retinal thickness-=>250µm
3.Point visual acuity less than 0.9
4.Patients who had received treatment with bevacizumab or ranibizumab for macular edema due to central retinal vein occlusion.
5.Age of patients 20years of age or older at the time of acquisition agreement.
6.After receiving a sufficient explanation upon participation in this study,on a full understanding,patients who obtained the document voluntary consent of the patient himself
Key exclusion criteria
1.Patients who underwent the pan-retinal photocoagulation within 3 months.
2.Patients who underwent photocoagulation treatment for macular edema within 3 months.
3.Patients treated with steroids to intraocular within 3 months.
4.The patients with a history of hypersensitivity to the study drug.
5.Patients who developed heart and cerebrovascular disease severe within 6 months.
6.Patients attending physician was deemed inappropriate as a subject.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kitaoka |
Organization
Nagasaki University Hospital
Division name
Ophthalmology
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7345
tkitaoka@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makiko Matsumoto |
Organization
Nagasaki University Hospital
Division name
Ophthalmology
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7345
Homepage URL
makimaki@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 06 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 30 | Day |
Last modified on
| 2019 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016430
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