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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016867
Receipt No. R000019576
Scientific Title Investigation of the treat-and-extend protocol with Aflibercept in combination with retinal photocoagulation in patients with diabetic macula edema
Date of disclosure of the study information 2015/04/01
Last modified on 2015/03/22

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Basic information
Public title Investigation of the treat-and-extend protocol with Aflibercept in combination with retinal photocoagulation in patients with diabetic macula edema
Acronym Investigation of the T&E protocol with IVA in combination with retinal photocoagulation in DME patients
Scientific Title Investigation of the treat-and-extend protocol with Aflibercept in combination with retinal photocoagulation in patients with diabetic macula edema
Scientific Title:Acronym Investigation of the T&E protocol with IVA in combination with retinal photocoagulation in DME patients
Region
Japan

Condition
Condition Diabetic macula edema
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To assess the efficacy of the treat-and-extend protocol with Aflibercept in combination with retinal photocoagulation in patients with diabetic macula edema.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Central retinal thickness (CRT) measured on optical coherence tomography (OCT) and visual acuity
Key secondary outcomes Number of intravitreal injections of aflibercept and safety

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 (genetical recombination) 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with type 1 or type 2 diabetes mellitus 20 years of age or older
Patients with fovea involving diabetic macular edema (judged with central subfield thickness on OCT)
Patients with reduced visual acuity associated with diabetic macular edema
Patients whose best corrected visual acuity is more than 20/320 (24 letters) by the ETDRS visual acuity test.
Patients with a central retinal thickness (CRT) of 300 um or more on the OCT retinal map (measured in mm) as an objective finding
Patients who are willing and able to visit the study site, as scheduled, and undergo scheduled examinations in this study
Patients who can provide written voluntary consent to participate in this study after receiving adequate explanation




Key exclusion criteria The condition of the fellow eye is worse than that of the study eye.
A history of vitreous surgery, including encircling buckling
Any retinal photocoagulation treatment within 90 days
Topical corticosteroid treatment within 120 days
Treatment with injection of any anti VEGF agent into the study eye within 90 days
Highly active, proliferative diabetic retinopathy in the study eye
A history of uveitis
Aphakic eyes
A history of any intraocular surgery in the study eye within the previous 90 days
It is considered difficult to improve visual acuity due to morphological changes
Glaucoma with poor IOP control, a history of glaucoma filtering surgery, or scheduled filtering surgery in the study eye
IOP of the study eye: more than 25 mmHg
Myopia of -8D or greater
Optic media in which it is difficult to obtain fundus photographs or OCT images
Severe systemic infections at baseline
Systemic anticoagulation therapy within 180
Poorly controlled diabetes mellitus
Poorly controlled hypertension
A history of cerebrovascular accident and/or myocardial infarction within 180 days
Patients on dialysis and patients with renal failure requiring dialysis

Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinori Murata
Organization Shinshu University
Division name Department of ophthalmology
Zip code
Address 3-1-1 Asahi,Matsumoto,390-8621 Japan
TEL +81-263-37-2664
Email murata@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takao Hirano
Organization Shinshu University
Division name Department of ophthalmology
Zip code
Address 3-1-1 Asahi,Matsumoto,390-8621 Japan
TEL +81-263-37-2664
Homepage URL
Email takaoh@shinshu-u.ac.jp

Sponsor
Institute Shinshu University Department of ophthalmology
Institute
Department

Funding Source
Organization Bayer Yakuhin
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 滋賀医科大学附属病院(滋賀県)
福井大学附属病院(福井県)
三重大学附属病院(三重県)
筑波大学附属病院(茨城県)
筑波大学附属病院水戸地域医療教育センター総合病院
九州大学附属病院(福岡県)
旭川医科大学附属病院(北海道)
北海道大学附属病院(北海道)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 01 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 Preinitiation
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 22 Day
Last modified on
2015 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019576

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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