UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001432
Receipt number R000001708
Scientific Title Evaluation of difluprednate ophthalmic emulsionfor macular edema and neovascular desease
Date of disclosure of the study information 2010/09/30
Last modified on 2021/03/20 10:54:00

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Basic information

Public title

Evaluation of difluprednate ophthalmic emulsionfor macular edema and neovascular desease

Acronym

Evaluation of difluprednate ophthalmic emulsionfor macular edema and neovascular desease

Scientific Title

Evaluation of difluprednate ophthalmic emulsionfor macular edema and neovascular desease

Scientific Title:Acronym

Evaluation of difluprednate ophthalmic emulsionfor macular edema and neovascular desease

Region

Japan


Condition

Condition

macular edema, neovascular eye desease

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of efficacy and safety of Durezol for macular edema and neovascular desease.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Foveal thickness

Key secondary outcomes

Visual acuity


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Difluprednate ophthalmic emulsion is instilled 4 times a day for the first month and then twice a day for 2 months.

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

The patients with diabetic macular edema and with mean foveal thickness more than 300 micro meter.

Key exclusion criteria

The patients with intraocular pressure more than 21 mmHg.
Patients diagnosed as steroid responder.

Target sample size

130


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hidetoshi Yamashita

Organization

Yamagata University,Faculty of Medicine

Division name

Depertment of Ophthalmology

Zip code


Address

2-2-2 iida-nishi,Yamagata

TEL

023-628-5374

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Yamagata University,Faculty of Medicine

Division name

Depertment of Ophthalmology

Zip code


Address


TEL

023-628-5374

Homepage URL


Email



Sponsor or person

Institute

Yamagata University,Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Yamagata University,Faculty of Medicine

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2010 Year 09 Month 30 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

84

Results

Mean retinal thickness decreased significantly in patients who completed difluprednate ophthalmic emulsion instillation, and retinal thickness decreased by 20% or more in 37% of cases. No serious complications were observed.

Results date posted

2021 Year 03 Month 20 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

This trial included 69 eyes of 48 cases in men, 49 eyes of 36 cases in women.The mean age was 63.3 years, and all patients had diabetic macular edema.The mean logMAR visual acuity before instillation in all eyes was 0.39, and the mean foveal retinal thickness was 474.7 um.The severity of diabetic retinopathy was 6 eyes for moderate non-proliferative diabetic retinopathy, 56 eyes for severe non-proliferative diabetic retinopathy, 46 eyes for proliferative diabetic retinopathy. Panretinal photocoagulation was performed in 90 eyes.There were 62 phakic eyes and 56 pseudophakic eyes at baseline. 34 eyes had a history

Participant flow

In 94 eyes of 66 cases completed the eye drop treatment specified in the protocol. After the start of instillation, 24 eyes of 18 cases were discontinued, and most of the reasons were increased intraocular pressure (16 eyes in 12 cases).
The number of cases did not reach the originally planned number.

Adverse events

Intraocular pressure increased to 25 mmHg or more during Durezol instillation in 24 of 118 eyes, but all cases decreased to 21 mmHg or less after discontinuation of Durezol instillation or instillation of intraocular pressure lowering drug.
There was no onset of infection in all eyes.

Outcome measures

visual acuity, retinal thickness

Plan to share IPD

none

IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2008 Year 10 Month 15 Day

Date of IRB

2008 Year 09 Month 22 Day

Anticipated trial start date

2008 Year 11 Month 01 Day

Last follow-up date

2020 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2008 Year 10 Month 16 Day

Last modified on

2021 Year 03 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001708


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name