UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027618 |
|---|---|
| Receipt number | R000030765 |
| Scientific Title | The effect of an anti-VEGF drug on proliferative diabetic retinopathy complicated with diabetic macular edema |
| Date of disclosure of the study information | 2017/06/03 |
| Last modified on | 2020/06/08 12:16:50 |
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Basic information
Public title
The effect of an anti-VEGF drug on proliferative diabetic retinopathy complicated with diabetic macular edema
Acronym
The effect of an anti-VEGF drug on proliferative diabetic retinopathy
Scientific Title
The effect of an anti-VEGF drug on proliferative diabetic retinopathy complicated with diabetic macular edema
Scientific Title:Acronym
The effect of an anti-VEGF drug on proliferative diabetic retinopathy
Region
| Japan |
Condition
Condition
proliferative diabetic retinopathy complicated with diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of intravitreal administration of aflibercept on retinal nonperfusion area of diabetic retinopathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
retinal nonperfusion area in fluorescein fundus angiography after administration of aflibercept
Key secondary outcomes
best corrected visual acuity, macular retinal thickness measured by optical coherence tomography, number of retinal neovasculature, grade of neovascularization on the optic nerve head, grade of neovascularization on the iris
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 (as gene recombinant) 2 mg (0.05 mL) is administered intravitreally three consecutive times once a month. After that, it is injected intravitreally once every 2 months, 7 times in total until 12 months after the first medication.
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
Diagnosed as diabetic retinopathy comlicated with diabetic macular edema, and detected retinal nonperfusion area by fluorescein fundus angiography examination.
Key exclusion criteria
In case of receiving intravitreal administration of anti-VEGF drug within 3 months before enrollment.
When panretinal or partial retinal photocoagulation was performed for the purpose of treatment against diabetic retinopathy within 3 months before starting participation.
During systemic administration of anti-VEGF drug.
Pregnant women or potential patients.
Patients judged inappropriate as subjects by research managers.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kitano Shigehiko |
Organization
Tokyo Women's Medical University
Division name
The department of ophthalmologyof Diabetes Center
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
ge2s-ktn@asahi-net.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kitano Shigehiko |
Organization
Tokyo Women's Medical University
Division name
The department of ophthalmologyof Diabetes Center
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
Homepage URL
ge2s-ktn@asahi-net.or.jp
Sponsor or person
Institute
Tokyo Women's 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
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
| 2017 | Year | 06 | Month | 03 | 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
Suspended
Date of protocol fixation
| 2017 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2017 | Year | 06 | Month | 03 | Day |
Last modified on
| 2020 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030765
