UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of microaneurysms using intravitreal faricimab for diabetic macular edema
Acronym	Evaluation of microaneurysms using intravitreal faricimab for diabetic macular edema
Scientific Title	Evaluation of microaneurysms using intravitreal faricimab for diabetic macular edema
Scientific Title:Acronym	Evaluation of microaneurysms using intravitreal faricimab for diabetic macular edema
Region	Japan

Condition
Condition	diabetic macular edema
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluating microaneurysms before and after treatment of farisimab in diabetic macular edema
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in the number of microaneurysms
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 who received farisimab for DME from the Department of Ophthalmology, University of Fukui Hospital between August 1, 2022 and December 31, 2024
Key exclusion criteria	Patients who refused to be enrolled in this study. Patients who were unable to undergo ophthalmologic examination due to cognitive or physical factors. Other cases in which the principal investigator determines that the patient is inappropriate as a research subject.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name yoshihiro Middle name Last name takamura
Organization	university of Fukui Hospital
Division name	Ophthalmology
Zip code	9101193
Address	23-3, matcuoka shimoaituki, eiheiji-cho, yoshida-gun, Fukui
TEL	0776-61-8403
Email	ytakamura@hotmail.com

Public contact
Name of contact person	1st name yutaka Middle name Last name yamada
Organization	university of Fukui Hospital
Division name	Ophthalmology
Zip code	9101193
Address	23-3, matcuoka shimoaituki, eiheiji-cho, yoshida-gun, Fukui
TEL	0776-61-8403
Homepage URL
Email	yyutaka@u-fukui.ac.jp

Sponsor
Institute	university of Fukui Hospital
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	university of Fukui Hospital
Address	23-3, matcuoka shimoaituki, eiheiji-cho, yoshida-gun, Fukui
Tel	0776-61-8403
Email	ytakamura@hotmail.com

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	2022 Year 11 Month 16 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	Open public recruiting
Date of protocol fixation	2022 Year 08 Month 01 Day
Date of IRB	2022 Year 11 Month 16 Day
Anticipated trial start date	2022 Year 08 Month 01 Day
Last follow-up date	2025 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing particular

Management information
Registered date	2022 Year 11 Month 16 Day
Last modified on	2022 Year 11 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056304