UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019635 |
|---|---|
| Receipt number | R000022341 |
| Scientific Title | Exploratory clinical study to examine the efficacy of the simultaneous subthreshold retinal-photocoagulation and the intravitreal injection of VEGF inhibitors for diabetic macular edema |
| Date of disclosure of the study information | 2015/11/09 |
| Last modified on | 2022/05/04 20:14:40 |
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Basic information
Public title
Exploratory clinical study to examine the efficacy of the simultaneous subthreshold retinal-photocoagulation and the intravitreal injection of VEGF inhibitors for diabetic macular edema
Acronym
Simultaneous subthreshold retinal-photocoagulation and intravitreal injection of VEGFinhibitors for DME
Scientific Title
Exploratory clinical study to examine the efficacy of the simultaneous subthreshold retinal-photocoagulation and the intravitreal injection of VEGF inhibitors for diabetic macular edema
Scientific Title:Acronym
Simultaneous subthreshold retinal-photocoagulation and intravitreal injection of VEGFinhibitors for DME
Region
| Japan |
Condition
Condition
Diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Eyes received either intravitreal VEGF inhibitors injection independent therapy or combination therapy of VEGF inhibitors and subthreshold photocoagulation.
A purpose of this study is to evaluate whether we can reduce the number of the dosage of the VEGF inhibitors by combination therapy, and to examine the effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A period before re-injection : A period before re-injection being necessary after the 3 consecutive monthly intravitreal injection of VEGF inhibitors
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
intravitreal injection of VEGF inhibitors
Interventions/Control_2
intravitreal injection of VEGF inhibitors
subthreshold retinal-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
1) Japanese male and female >= 18 years with type 1 or 2 diabetes mellitus
2) DME with central involvementin the study eye
3) Decrease in vision determined to be primarily the result of DME in the study eye
4) central macular thickness >= 300um in the study eye
5)BCVA of 0.7 to 0.05 in the study eye
Key exclusion criteria
Laser photocoagulation (panretinal or macular) in the study eye within 90 days of day 1
Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1
Previous treatment with anti-angiogenic drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc.) within 90 days of day 1
Active proliferative diabetic retinopathy (PDR) in the study eye
Uncontrolled diabetes mellitus
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Yamamoto |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan
TEL
043-222-7171
shuyama@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Tomoaki |
| Middle name | |
| Last name | Tatsumi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan
TEL
043-222-7171
Homepage URL
ttatsumi@chiba-u.jp
Sponsor or person
Institute
Department of Ophthalmology and Visual Science, Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin Ltd
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
Chiba Univeratiy Certified Clinical Research Review Board
Address
1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan
Tel
043-226-2616
prc-jim@chiba-u.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs031180182
Org. issuing International ID_1
Japan Registry of Clinical Trialas
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部附属病院（千葉県）、千葉ろうさい病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 09 | 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
51
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 | 10 | Month | 14 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 04 | Day |
Last modified on
| 2022 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022341
