UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of microaneurysms density before and after injection of anti-vascular endothelial growth factor in diabetic macular edema
Acronym	Evaluation of microaneurysms density before and after injection of anti-vascular endothelial growth factor in diabetic macular edema
Scientific Title	Evaluation of microaneurysms density before and after injection of anti-vascular endothelial growth factor in diabetic macular edema
Scientific Title:Acronym	Evaluation of microaneurysms density before and after injection of anti-vascular endothelial growth factor in diabetic macular edema
Region	Japan

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

Objectives
Narrative objectives1	To estimate the effectiveness of anti-vascular endothelial growth factor (VEGF) therapy in terms of microaneurysms density in diabetic macular edema (DME).
Basic objectives2	Others
Basic objectives -Others	using fluorescein angiography and optical coherence tomography
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	microaneurysms density before and after anti-VEGF drugs in DME
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	diagnosed with type 2 diabetes mellitus with DME
Key exclusion criteria	other retinal disease
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Yoshihiro Middle name Last name Takamura
Organization	university of fukui
Division name	Ophthalmology
Zip code	9101193
Address	23-3 shimoaiduki matuoka eiheijcho Fukui
TEL	0776-61-3111
Email	ytakamura@hotmail.com

Public contact
Name of contact person	1st name Yoshihiro Middle name Last name Takamura
Organization	university of fukui
Division name	Ophthalmology
Zip code	9101193
Address	23-3 shimoaiduki matuoka eiheijcho Fukui
TEL	0776-61-3111
Homepage URL
Email	ytakamura@hotmail.com

Sponsor
Institute	university of fukui
Institute
Department

Funding Source
Organization	university of fukui
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
Address	23-3 shimoaiduki matuoka eiheijcho Fukui
Tel	0776-61-3111
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	2019 Year 06 Month 10 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	73
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	No longer recruiting
Date of protocol fixation	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 08 Month 24 Day
Anticipated trial start date	2018 Year 09 Month 11 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This retrospective study includes DME patients underwent anti VEGF drugs injection. We divided patients into 2 groups (disappeared group and remained group) by effectiveness of single anti-VEGF therapy. We manually merged fluorescein angiography (FA) at baseline and optical coherence tomography (OCT) map at before and after injection in each patient. We located MAs and calculated MA densities in highly thickened area in each group.

Management information
Registered date	2019 Year 06 Month 04 Day
Last modified on	2019 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042051