UMIN-CTR Clinical Trial

Basic information
Public title	The effect of NSAID for the cystoid macular edema after panretinal photocoagulation in diabetic retinophathy
Acronym	The effect of NSAID for the cystoid macular edema after panretinal photocoagulation in diabetic retinophathy
Scientific Title	The effect of NSAID for the cystoid macular edema after panretinal photocoagulation in diabetic retinophathy
Scientific Title:Acronym	The effect of NSAID for the cystoid macular edema after panretinal photocoagulation in diabetic retinophathy
Region	Japan

Condition
Condition	diabetic retinopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the effect of NSAID eye drop for cystoid macular edema after panretinal photocoagulation for diabetic retinopathy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	retina thickness by OCT and cystoid macular edema by FA
Key secondary outcomes	visual acuity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	NSAID eye drops
Interventions/Control_2	vitamin eye drops
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	HbA1c is under 9%. Preproliferative or proliferative diabetic retinopathy. Need panretinal photocoagulation . Visual acuity is over 20/50. Retinal thickness is under 400maicro-meter.
Key exclusion criteria	Cannot recieve informed concent. Treated by NSAID for these 6 months. Already recieved panretinal photocoagulation. Treated photocoagulation except pan retinal photocoagulation for these 6 months. Not suitable for this study.
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobuhiro Ibaraki
Organization	Jichi medical University
Division name	Department of Ophthalmology
Zip code
Address	3311-1 Yakushiji, Shimotsuke-city, Tochigi
TEL	0285-58-7382
Email

Public contact
Name of contact person	1st name Middle name Last name Nobuhiro Ibaraki
Organization	Jichi Medical University
Division name	Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
Email	ibaraki@jichi.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	Dept. of Ophthalmol., Jichi Medical University
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
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	2009 Year 01 Month 19 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
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
Date of protocol fixation	2009 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date	2009 Year 01 Month 01 Day
Last follow-up date	2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 01 Month 19 Day
Last modified on	2009 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001980

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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