UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036949
Receipt number R000042051
Scientific Title Evaluation of microaneurysms density before and after injection of anti-vascular endothelial growth factor in diabetic macular edema
Date of disclosure of the study information 2019/06/10
Last modified on 2019/06/04 08:26:19

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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 or person

Institute

university of fukui

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042051


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name