UMIN-CTR Clinical Trial

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
Institute	Yamagata University,Faculty of Medicine
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001708