UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of inravitreal ranibizumab therapy with and without laser photocoagulation for diabetic macular edema.
Acronym	Comparison of inravitreal ranibizumab therapy with and without laser photocoagulation for diabetic macular edema.
Scientific Title	Comparison of inravitreal ranibizumab therapy with and without laser photocoagulation for diabetic macular edema.
Scientific Title:Acronym	Comparison of inravitreal ranibizumab therapy with and without laser photocoagulation for diabetic macular edema.
Region	Japan

Condition
Condition	diabetic macular edema
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare efficacy and safty of intravitreal ranibizumad injection with and without laser photocoagulation for diabetic macular edema.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change from baseline in best-crrected visual acuity at 18 months.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Ranibizumab monotherapy
Interventions/Control_2	Ranibizumab/Laser photocoagulation
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	Over 20 years old. HbA1c under 10%. Diabetic macular edema with central subfield thickness over 250um. Best-correctd visual acuity over 20/200.
Key exclusion criteria	Other ocular disease. Laser photocoagulation within 3 months. Anti-VEGF therapy within 3 months. Focal steroid injection within 3 months. Diabetic retinopthy over 85 ETDRS grades. After any vitrectomy. After cataract surgery. Focal diabetic macular edema.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Shigehiko Middle name Last name Kitano
Organization	Tokyou Women's Medicai University
Division name	Department of Ophthalomology, Diabetes Center
Zip code	162-8666
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Email	ge2s-ktn@asahi-net.or.jp

Public contact
Name of contact person	1st name Shigehiko Middle name Last name Kitano
Organization	Tokyou Women's Medicai University
Division name	Department of Ophthalomology, Diabetes Center
Zip code	162-8666
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Homepage URL
Email	ge2s-ktn@asahi-net.or.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Novartis Pharma
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Center for Global Health and Medicine
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
Tel	03-3202-7181
Email	kennkyu-shinsa@hosp.ncgm.go.jp

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	2016 Year 11 Month 07 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	Completed
Date of protocol fixation	2014 Year 06 Month 30 Day
Date of IRB	2014 Year 07 Month 08 Day
Anticipated trial start date	2015 Year 08 Month 07 Day
Last follow-up date	2020 Year 10 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 11 Month 03 Day
Last modified on	2022 Year 05 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028339