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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025234
Receipt No. 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

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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
Email 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
Email itoyuji@eye-center.org

Sponsor
Institute Kyorin Eye Center, Kyorin University School of Medicine
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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029026

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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