UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022476 |
|---|---|
| Receipt number | R000025899 |
| Scientific Title | The efficacy of the treat and extend protocol with Aflibercept for diabetic macula edema |
| Date of disclosure of the study information | 2016/05/26 |
| Last modified on | 2020/08/23 11:49:36 |
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Basic information
Public title
The efficacy of the treat and extend protocol with Aflibercept for diabetic macula edema
Acronym
The efficacy of the treat and extend protocol with Aflibercept for diabetic macula edema
Scientific Title
The efficacy of the treat and extend protocol with Aflibercept for diabetic macula edema
Scientific Title:Acronym
The efficacy of the treat and extend protocol with Aflibercept for diabetic macula edema
Region
| Japan |
Condition
Condition
Diabetic macula edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the treat and extend protocol with Aflibercept for diabetic macula edema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity,central retinal thickness (CRT) measured on optical coherence tomography (OCT)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aflibercept will be administered by intravitreal injection at a dose of 2mg (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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with type 1 or type 2 diabetes mellitus 20 years of age or older
2.Patients with fovea involving diabetic macular edema
3.Patients with reduced visual acuity associated with diabetic macular edema
4.Patients whose best corrected visual acuity is less than or equal to 6/10
5.Patients with a central retinal thickness (CRT) of 300 um or more on the OCT
Key exclusion criteria
1.A history of vitreous surgery, including encircling buckling
2.Any retinal photocoagulation treatment or treatment with injection of any anti VEGF agent within 90 days
3.Highly active, proliferative diabetic retinopathy
4.A history of ocular inflammation
5.A history of any intraocular surgery within the previous 90 days
6.Aphakic eyes
7.Contrast medium allergy
8.It is considered difficult to improve visual acuity due to morphological changes
9.Glaucoma with poor IOP control,or IOP of the study eye: more than 25 mmHg
10.Myopia of -8D or greater
11.Severe systemic infections
12.Treatment with carcinostatic agent
13.Uncontrolled diabetes mellitus,as defined by HbA1c >12%
14.Uncontrolled blood pressure,defined as systolic >180 mmHg or diastolic >100 mmHg while subject is sitting)
15.A history of cerebrovascular accident and/or myocardial infarction within 180 days
16.Patients on dialysis and patients with renal failure requiring transplantation
17.Pregant or lactating
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chie Sotozono |
Organization
Kyoto Prefecture University of Medicine
Division name
Depertment of ophthalmology
Zip code
Address
465 Kajiityo,Kyoto,Japan
TEL
0752515578
csotozon@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Mieno |
Organization
Kyoto Prefecture University of Medicine
Division name
Depertment of ophthalmology
Zip code
Address
465 Kajiityo,Kyoto,Japan
TEL
0752515578
Homepage URL
hmieno@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefecture University of Medicine
Depertment of ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Bayer HealthCare
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 | 05 | Month | 26 | 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
| 2015 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 07 | 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
| 2016 | Year | 05 | Month | 26 | Day |
Last modified on
| 2020 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025899
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