UMIN-CTR Clinical Trial

Basic information
Public title	The effect of an anti-VEGF drug on proliferative diabetic retinopathy complicated with diabetic macular edema
Acronym	The effect of an anti-VEGF drug on proliferative diabetic retinopathy
Scientific Title	The effect of an anti-VEGF drug on proliferative diabetic retinopathy complicated with diabetic macular edema
Scientific Title:Acronym	The effect of an anti-VEGF drug on proliferative diabetic retinopathy
Region	Japan

Condition
Condition	proliferative diabetic retinopathy complicated with diabetic macular edema
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of intravitreal administration of aflibercept on retinal nonperfusion area of diabetic retinopathy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	retinal nonperfusion area in fluorescein fundus angiography after administration of aflibercept
Key secondary outcomes	best corrected visual acuity, macular retinal thickness measured by optical coherence tomography, number of retinal neovasculature, grade of neovascularization on the optic nerve head, grade of neovascularization on the iris

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Aflibercept (as gene recombinant) 2 mg (0.05 mL) is administered intravitreally three consecutive times once a month. After that, it is injected intravitreally once every 2 months, 7 times in total until 12 months after the first medication.
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	Diagnosed as diabetic retinopathy comlicated with diabetic macular edema, and detected retinal nonperfusion area by fluorescein fundus angiography examination.
Key exclusion criteria	In case of receiving intravitreal administration of anti-VEGF drug within 3 months before enrollment. When panretinal or partial retinal photocoagulation was performed for the purpose of treatment against diabetic retinopathy within 3 months before starting participation. During systemic administration of anti-VEGF drug. Pregnant women or potential patients. Patients judged inappropriate as subjects by research managers.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kitano Shigehiko
Organization	Tokyo Women's Medical University
Division name	The department of ophthalmologyof Diabetes Center
Zip code
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-8111
Email	ge2s-ktn@asahi-net.or.jp

Public contact
Name of contact person	1st name Middle name Last name Kitano Shigehiko
Organization	Tokyo Women's Medical University
Division name	The department of ophthalmologyof Diabetes Center
Zip code
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-8111
Homepage URL
Email	ge2s-ktn@asahi-net.or.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Bayer Yakuhin, Ltd.
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	2017 Year 06 Month 03 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	Suspended
Date of protocol fixation	2017 Year 03 Month 02 Day
Date of IRB	2017 Year 03 Month 02 Day
Anticipated trial start date	2017 Year 06 Month 03 Day
Last follow-up date	2020 Year 03 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	2017 Year 06 Month 03 Day
Last modified on	2020 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030765