UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017818
Receipt number R000020638
Scientific Title Anti-VEGF monotherapy versus combined anti-VEGF and end-point-management grid laser photocoagulation for diabetic macular edema
Date of disclosure of the study information 2015/06/05
Last modified on 2017/06/05 11:55:39

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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 or person

Institute

University of Hong Kong, Nagoya City University Graduate school of Medical Sciences

Institute

Department

Personal name



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

Value
https://center6.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