UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The prospective study searching for the frequency of the endophthalmitis without antibiotic eye drop before and after a intravitreal injection to the macular diseases.
Title of the study (Brief title)	The frequency of the endophthalmitis without antibiotic eye drop before and after a intravitreal injection
Region	Japan

Condition
Condition	Macular diseases
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To know when washing and sterilizing bacteria in the ocular surface with povidone iodine during an injection, it does not need before and after antibiotic eye drop for intravitreal injection.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The frequency of endophthalmitis 1 month after intravitreal injection
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intravitreal injections without antibacterial medicine
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	The patients of age-related macular degeneration, retinal vein occulusion, diabetic macular edema and myopic choroidal neovascularization who need intravitreal injection of anti-VEGF.
Key exclusion criteria	Compromised patient and have a allergy for povidone iodine
Target sample size	15500

Research contact person
Name of lead principal investigator	Hiroyuki Shimada
Organization	Nihon university hospital
Division name	Ophthalmology
Address	1-6 Kandasurugadai Chiyoda-ku Tokyo Japan
TEL	0332931711
Email	shimada.hiroyuki@nihon-u.ac.jp

Public contact
Name of contact person	Koji Tanaka
Organization	Nihon university hospital
Division name	Ophthalmology
Address	1-6 Kandasurugadai Chiyoda-ku Tokyo Japan
TEL	0332931711
Homepage URL
Email	tanaka.koji@nihon-u.ac.jp

Sponsor
Institute	Nihon University School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	日本大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 13 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2017 Year 11 Month 30 Day
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 03 Month 10 Day
Last modified on	2018 Year 01 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024392