UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the treat-and-extend protocol with Aflibercept in combination with retinal photocoagulation in patients with diabetic macula edema(extension study)
Title of the study (Brief title)	Investigation of the T&E protocol with IVA in combination with retinal photocoagulation in DME patients(extension study)
Region	Japan

Condition
Condition	Diabetic macula edema
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

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 4 weeks.
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	20

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

Public contact
Name of contact person	Yuichi Toriyama
Organization	Shinshu University
Division name	Department of ophthalmology
Address	Asahi,Matsumoto,390-8621 Japan
TEL	+81-263-37-2664
Homepage URL
Email	ytoriyama@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)

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	2017 Year 07 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 06 Month 06 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 15 Day
Last modified on	2017 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031572