UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039134
Receipt number R000044632
Scientific Title The efficacy influenced on the timing of anti-VEGF treatment in pro re nata regimen for recurrence of diabetic macular edema
Date of disclosure of the study information 2020/01/13
Last modified on 2022/07/15 15:13:07

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Basic information

Public title

The efficacy influenced on the timing of anti-VEGF treatment in pro re nata regimen for recurrence of diabetic macular edema

Acronym

The efficacy influenced on the timing of anti-VEGF treatment for DME

Scientific Title

The efficacy influenced on the timing of anti-VEGF treatment in pro re nata regimen for recurrence of diabetic macular edema

Scientific Title:Acronym

The timing of anti-VEGF treatment for DME

Region

Japan


Condition

Condition

Diabetic macular edema

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether the efficacy of anti-vascular endothelial growth factor (VEGF) treatment in pro re nata (PRN) regimen for diabetic macular edema (DME) was influenced on the duration until the intravitreal injection of ranibizumab (IVR) and aflibercept (IVA) from the date detected the recurrence of diabetic macular edema (DME).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

central retinal thickness, visual acuity

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

waiting time is less than 1 week

Interventions/Control_2

waiting time is more than 1 month

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with type 2 diabetes with DME who underwent intravitreal injection of anti-VEGF agent in 1+PRN regimen

Key exclusion criteria

(1) <20 years of age; 2) focal/grid photocoagulation or panretinal photocoagulation within the previous 6 months; (3) active intraocular inflammation or infection in either eye; (4) uncontrolled glaucoma in either eye; (5) a history of intravitreal injections of steroids during the observational periods; (6) a history of stroke; (7) a systolic blood pressure (BP) > 160 mm Hg, a diastolic BP > 100 mm Hg or untreated hypertension and (8) glycosylated hemoglobin (HbA1c) more than 10%.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yoshihiro
Middle name
Last name Takamura

Organization

Faculty of Medical Sciences, University of Fukui

Division name

Department of Ophthalmology

Zip code

918-8205

Address

23-3 Matsuoka, Eiheiji, Yoshida, Fukui, Japan.

TEL

+81-776-61-8403

Email

ytakamura@hotmail.com


Public contact

Name of contact person

1st name Yoshihiro
Middle name
Last name Takamura

Organization

Faculty of Medical Sciences, University of Fukui

Division name

Department of Ophthalmology

Zip code

918-8205

Address

23-3 Matsuoka, Eiheiji, Yoshida, Fukui, Japan.

TEL

+81-776-61-8403

Homepage URL


Email

ytakamura@hotmail.com


Sponsor or person

Institute

Faculty of Medical Sciences, University of Fukui

Institute

Department

Personal name



Funding Source

Organization

Faculty of Medical Sciences, 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

Faculty of Medical Sciences, University of Fukui

Address

23-3 Matsuoka, Eiheiji, Yoshida, Fukui, Japan.

Tel

+81-776-61-8403

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

2020 Year 01 Month 13 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/34945035/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/34945035/

Number of participants that the trial has enrolled

141

Results

CRT in the deferred group was significantly higher than that in the prompt group at 2, 5, 6, 7, and 12 months (p < 0.05). BCVA in the prompt group was significantly better than that in the deferred group at 7, 10, and 12 months (p < 0.05).

Results date posted

2022 Year 07 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

patients with Diabetic macular edema CRT more than 300 who underwent intraocular injections of ranibizumab or aflibercept in 1 +PRN regimen.

Participant flow

Retrospective, multicenter

Adverse events

None

Outcome measures

Central retinal thickness
Visual acuity
number of injections

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2019 Year 12 Month 25 Day

Date of IRB

2019 Year 12 Month 19 Day

Anticipated trial start date

2020 Year 01 Month 11 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 01 Month 12 Day

Last modified on

2022 Year 07 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044632


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name