UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048935
Receipt number R000055740
Scientific Title A Multi-Institutional Study of the Impact of the COVID-19 Pandemic on Diagnosis and Pharmacotherapy of Diabetic Macular Edema
Date of disclosure of the study information 2022/09/14
Last modified on 2023/04/05 09:01:00

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Basic information

Public title

A Multi-Institutional Study of the Impact of the COVID-19 Pandemic on Diagnosis and Pharmacotherapy of Diabetic Macular Edema

Acronym

A Multi-Institutional Study of the Impact of the COVID-19 Pandemic on Diagnosis and Pharmacotherapy of Diabetic Macular Edema

Scientific Title

A Multi-Institutional Study of the Impact of the COVID-19 Pandemic on Diagnosis and Pharmacotherapy of Diabetic Macular Edema

Scientific Title:Acronym

A Multi-Institutional Study of the Impact of the COVID-19 Pandemic on Diagnosis and Pharmacotherapy of Diabetic Macular Edema

Region

Japan


Condition

Condition

Diabetic Macular Edema

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

By analyzing the effect of COVID-19 infection on the alteration of consciousness of ophthalmologists and on the diagnosis and treatment of DME, we can define the social significance of infectious diseases including COVID-19 in the field of ophthalmology and help build a better medical system in the future.

Basic objectives2

Others

Basic objectives -Others

Changes in the number of intravitreal injections of anti-VEGF drugs during the COVID-19 epidemic in Japan

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Association between the number of intravitreal injections of anti-VEGF drugs for diabetic macular edema after a COVID-19 outbreak (January 1, 2020 to March 18, 2022) and the number of new COVID-19 infections.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who received intravitreal injections of aflibercept, ranibizumab, or triamcinolone acetonide for diabetic macular edema at the study institution between January 1, 2019, and March 18, 2022

Key exclusion criteria

Patients who refused to enroll in this study or who were participating in other clinical trials

Target sample size

20000


Research contact person

Name of lead principal investigator

1st name Ryohei
Middle name
Last name Komori

Organization

University of Fukui Hospital

Division name

ophthalmology

Zip code

910-1193

Address

23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui

TEL

0776-61-3111

Email

fganka@med.u-fukui.ac.jp


Public contact

Name of contact person

1st name Ryohei
Middle name
Last name Komori

Organization

University of Fukui Hospital

Division name

ophthalmology

Zip code

910-1193

Address

23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui

TEL

0776-61-8403

Homepage URL


Email

fganka@med.u-fukui.ac.jp


Sponsor or person

Institute

University of Fukui Hospital

Institute

Department

Personal name



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 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui

Tel

0776-61-8403

Email

fganka@med.u-fukui.ac.jp


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 09 Month 14 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

18305

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

Completed

Date of protocol fixation

2022 Year 03 Month 10 Day

Date of IRB

2022 Year 03 Month 23 Day

Anticipated trial start date

2022 Year 09 Month 14 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

observational study


Management information

Registered date

2022 Year 09 Month 14 Day

Last modified on

2023 Year 04 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055740


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name