UMIN-CTR Clinical Trial

Basic information
Public title	Anti-VEGF monotherapy versus combined anti-VEGF and end-point-management grid laser photocoagulation for diabetic macular edema
Acronym	END-DME Study
Scientific Title	Anti-VEGF monotherapy versus combined anti-VEGF and end-point-management grid laser photocoagulation for diabetic macular edema
Scientific Title:Acronym	END-DME Study
Region	Japan Asia(except Japan)

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

Objectives
Narrative objectives1	To compare the efficacy of monotherapy with anti-VEGF (ranibizumab or bevacizumab) with combined therapy with anti-VEGF and end-point-management grid laser photocoagulation for diabetic macular edema.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Difference in number of Anti-VEGF injections required among the two treatment arms.
Key secondary outcomes	Change from baseline in BCVA and OCT. Time required achieving treatment success. BCVA and OCT outcome depending on the type of DME on presentation.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
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 Device,equipment
Interventions/Control_1	anti-VEGF monotherapy
Interventions/Control_2	anti-VEGF therapy and End-Point-Management (EPM) grid 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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	To be eligible, the following inclusion criteria must be met: Age; 18 years with CSME Diagnosis of diabetes mellitus (type 1 or type 2) At least one eye meets the study eye criteria Able and willing to provide informed consent prior to any study-related procedures Central foveal thickness; 300 microns at baseline (SPECTRALIS or Cirrus HD OCT) LogMAR Best corrected visual acuity 0.30 (Snellen 20/25) to 1.3 (Snellen 20/400). Willing and able to comply with clinic visits and study-related procedures Central Foveal Thickness on OCT 300-600 micron After first injection, wait for ME to reduce before proceeding with the laser. Exclude if ME persists >500um at the 4-week follow up
Key exclusion criteria	Macular edema is considered to be due to a cause other than diabetic macular edema. An ocular condition is present such that visual acuity loss would not improve from resolution of macular edema. Substantial cataract that is likely to be affecting visual acuity. Focal laser photocoagulation should be performed before enrolling into the study if needed. Three months gap required between last laser procedure and recruitment. History of panretinal (scatter) photocoagulation (PRP) within 3 months prior to enrollment. Anticipated need for PRP in the study period. History of major retinal surgery. History of YAG capsulotomy performed within 3 months. Aphakia. History of open-angle glaucoma. Exam evidence of external ocular infection. A subject is not eligible if any of the following exclusion criteria are present Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. A condition that would preclude participation in the study. Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months. Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization. pregnant or lactating or intending to become pregnant within the next 12 months.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ian Wong, Miho Nozaki
Organization	University of Hong Kong, Nagoya City University Graduate School of Medical Sciences
Division name	Ophthalmology
Zip code
Address	1 Kawasumi Mizuhocho Mizuho-ku Nagoya
TEL	052(853)8251
Email	nozakim@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Miho Nozaki
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Ophthalmology
Zip code
Address	1 Kawasumi Mizuo-cho Mizuho-ku Nagoya
TEL	052(853)8251
Homepage URL
Email	nozakim@mednagoya-cu.ac.jp

Sponsor
Institute	University of Hong Kong, Nagoya City University Graduate school of Medical Sciences
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	杏林大学アイセンター（東京都）、京都大学（京都府）、旭川医大（北海道）、福井大（福井県） 北海道大学（北海道）東京医科大学八王子医療センター（東京都） 九州大学（福岡県）、大阪医大（大阪府）江口眼科病院（北海道）、山形大（山形県）、長崎大（長崎県）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 05 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	2015 Year 04 Month 06 Day
Date of IRB
Anticipated trial start date	2015 Year 04 Month 06 Day
Last follow-up date	2017 Year 06 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 09 Month 06 Day

Other
Other related information

Management information
Registered date	2015 Year 06 Month 04 Day
Last modified on	2017 Year 06 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020638

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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