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
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
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
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
