UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017037 |
|---|---|
| Receipt number | R000019751 |
| Scientific Title | The study for the effect of intravitreous injection of ranibizumab (product name: Lucentis) and subthreshold laser photocoagulation on diabetic macular edema |
| Date of disclosure of the study information | 2015/04/20 |
| Last modified on | 2017/04/03 12:40:21 |
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Basic information
Public title
The study for the effect of intravitreous injection of ranibizumab (product name: Lucentis) and subthreshold laser photocoagulation on diabetic macular edema
Acronym
The study for the effect of combination therapy of intravitreous injection of ranibizumab and subthreshold laser photocoagulation on diabetic macular edema
Scientific Title
The study for the effect of intravitreous injection of ranibizumab (product name: Lucentis) and subthreshold laser photocoagulation on diabetic macular edema
Scientific Title:Acronym
The study for the effect of combination therapy of intravitreous injection of ranibizumab and subthreshold laser photocoagulation on diabetic macular edema
Region
| Japan |
Condition
Condition
diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to evaluate the effect of combination therapy of intravitreous injection of ranibizumab and subthreshold laser photocoagulatioin on diabetic macular edema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
best-corrected visual acuity (before treatment, 3 months later, 6 months later, 12 months later)
total number of injections (for 12 months)
change in central retinal subfield thickness (3 months later, 6 months later, 12 months later)
Key secondary outcomes
fluorescein angiography (before treatment, 3 months later, 6 months later, 12 months later)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Intravitreous injection of ranibizumab
Patients receive 3 initial consecutive monthly injections of ranibizumab. Additional injections are performed as needed.
Interventions/Control_2
Combination therapy of intravitreous injection of ranibizumab and subthreshold laser photocoagulation
Patients receive subthreshold laser photocoagulation 2 weeks after the first injection of ranibizumab.
Patients receive 3 initial consecutive monthly injections of ranibizumab. Additional injections are performed as needed.
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
Best corrected-visual acuity measured with a Landolt chart is 0.7 or less than 0.7.
HbA1c is less than 10%.
Over 3 months must pass since glycemic control begins.
Key exclusion criteria
Patients who receive occular surgical treatments within 3 months
Patients who receive other macular diseases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | FUMIHIKO TOYODA |
Organization
Jichi Medical University, Saitama Medical Center
Division name
Department of Ophthalmology
Zip code
Address
1-847Amanuma-cho, Omiya-ku,Saitama, Saitama, 330-8503, Japan
TEL
048-647-2111
ft80@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | AKIRA YANAI |
Organization
Jichi Medical University, Saitama Medical Center
Division name
General Affairs Division
Zip code
Address
1-847Amanuma-cho, Omiya-ku,Saitama, Saitama, 330-8503, Japan
TEL
048-647-2111
Homepage URL
yanaiakr@jichi.ac.jp
Sponsor or person
Institute
Jichi Medica University, Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
TOPCON CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Miyacho Ophthalmic Clinic, Shinkoukai medical corporation
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
自治医科大学附属さいたま医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 20 | 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 | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 03 | Day |
Last modified on
| 2017 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019751
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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