UMIN-CTR Clinical Trial

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
Email	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
Email	hmieno@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefecture University of Medicine Depertment of ophthalmology
Institute
Department

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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025899