UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of topical NSAIDs for anti-VEGF therapy for vitreomacular disease
Title of the study (Brief title)	The efficacy of topical NSAID
Region	Japan

Condition
Condition	retinal vein occlusion diabetic retinopathy age related macular degeneration
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effectiveness of topical NSAID for anti-VEGF treatment in vitreomacular disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Progression of visual acuity Regression of macular thickness
Key secondary outcomes	frequecy of anti-VEGF treatment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Topical NSAID for 1 year follow up
Interventions/Control_2	Topical artificial tear as placebo for 1 year follow up
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	Macular edema with diabetic retinopathy, retinal vein occlusion, or age-related macular degeneration. central macular thickness more than 400 mirometer. logMAR visual acuity between 0.5 and 1 treatment naive case senseitive to anti-VEGF therapy
Key exclusion criteria	macular ischemia ocular inflammation systemic disorder other than hypertension and hypercholesterolaemia
Target sample size	200

Research contact person
Name of lead principal investigator	Masahiko Shimura
Organization	Tokyo Medical University Hachioji Medical center
Division name	Department of Ophthalmology
Address	1163 Tate-machi, Hachioji Tokyo
TEL	0426655611
Email	masahiko@v101.vaio.ne.jp

Public contact
Name of contact person	Kanako Yasuda
Organization	Tokyo Medical University Hachioji Medical Center
Division name	Ophthalmology
Address	1163 Tate-machi, Hachioji Tokyo
TEL	0426655611
Homepage URL
Email	kana6723@yahoo.co.jp

Sponsor
Institute	NTT East japan Tohoku Hospital
Institute
Department

Funding Source
Organization	NTT East japan Tohoku Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	ＮＴＴ東日本東北病院（宮城県） 東京医科大学八王子医療センター（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 08 Month 24 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 04 Month 30 Day
Date trial data considered complete	2016 Year 04 Month 30 Day
Date analysis concluded	2016 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/27306783
Results
Other related information

Management information
Registered date	2014 Year 08 Month 23 Day
Last modified on	2018 Year 01 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017372