UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016867 |
|---|---|
| Receipt number | 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 09:51:55 |
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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
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
takaoh@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Department of ophthalmology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019576
