UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001646
Receipt No. R000001980
Scientific Title The effect of NSAID for the cystoid macular edema after panretinal photocoagulation in diabetic retinophathy
Date of disclosure of the study information 2009/01/19
Last modified on 2009/01/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.