UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025234 |
|---|---|
| Receipt number | R000029026 |
| Scientific Title | The efficacy of Eylea to treat proliferative diabetic retinopathy/preproliferative diabetic retinopathy in patients with diabetic macular edema |
| Date of disclosure of the study information | 2016/12/12 |
| Last modified on | 2018/12/22 10:15:46 |
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Basic information
Public title
The efficacy of Eylea to treat proliferative diabetic retinopathy/preproliferative diabetic retinopathy in patients with diabetic macular edema
Acronym
The efficacy of Eylea to treat proliferative diabetic retinopathy/preproliferative diabetic retinopathy in patients with diabetic macular edema
Scientific Title
The efficacy of Eylea to treat proliferative diabetic retinopathy/preproliferative diabetic retinopathy in patients with diabetic macular edema
Scientific Title:Acronym
The efficacy of Eylea to treat proliferative diabetic retinopathy/preproliferative diabetic retinopathy in patients with diabetic macular edema
Region
| Japan |
Condition
Condition
Diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary objective is to investigate the efficacy of Eylea on visual acuity and anatomical outcomes of proliferative diabetic retinopathy /preproliferative diabetic retinopathy patients with DME
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in Best-corrected visual acuity (BCVA) from baseline to month 12
Key secondary outcomes
1. BCVA at every visit
2. Change of CST at every visit
3. Evaluation of microaneurysm (MA) by OCT angiography at macula at every visit
4. Non perfusion area(NPA), Neovascularization elsewhere(NVE) and Neovascularization of disc(NVD) by FA at pretreatment and 12 month
5. Glycosylated hemoglobin levels (HbA1c) at every visit
6. Diabetic retinopathy severity scale (DRSS) at baseline, month 6 and 12
7. Intraocular pressure(IOP) at every visit
8. Fundus photograph at every visit
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 (Eylea) will be administered by intravitreal injection at a dose of 2 mg (0.05 mL) at intervals of at least 1 month.
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with type 1 and 2 diabetes, age > 18 years
2.Proliferative diabetic retinopathy (PDR)/Preproliferative diabetic retinopathy (PPDR) with DME
3.Visual impairment due to DME
4.Central subfield thickness(CST) >
300 microns
5.Decimal visual acuity 0.1-0.7
6.Patients who have given informed consent
Key exclusion criteria
1.Patient with neovascularization of the optic disc (NVD)
2.Eyes requiring immediate vitrectomy for reasons such as rhegmatogenous or traction retinal detachment
3.Patient with 2 or more NVE
4.Patient with non-perfusion area detected by FA (NPA, >10 disc diameter)
5.History of vitreoretinal surgery
6.History of laser photocoagulation within 3 months before study entry
7.History of intravitreal or peribulber corticosteroids within 3 months before study entry
8.History of ocular surgery within 3 months before study entry
9.History of anti-VEGF injection
10.HbA1c >12%
11.Patient who is judged inappropriate for study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akito Hirakata |
Organization
Kyorin University School of Medicine
Division name
Kyorin Eye Center
Zip code
Address
6-20-2 Shinkawa, Mitaka,Tokyo, Japan
TEL
0422-47-5511
hirakata@eye-center.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Ito |
Organization
Kyorin University School of Medicine
Division name
Kyorin Eye Center
Zip code
Address
6-20-2 Shinkawa, Mitaka,Tokyo, Japan
TEL
0422-47-5511
Homepage URL
itoyuji@eye-center.org
Sponsor or person
Institute
Kyorin Eye Center, Kyorin University School of Medicine
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
| 2016 | Year | 12 | Month | 12 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 04 | 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
| 2016 | Year | 12 | Month | 12 | Day |
Last modified on
| 2018 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029026
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| Registered date | File name |
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| Registered date | File name |
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