UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035829 |
|---|---|
| Receipt number | R000040816 |
| Scientific Title | The effect of intravitreal injection of ranibizumab before direct photocoagulation in the treatment of focal diabetic macular edema |
| Date of disclosure of the study information | 2019/02/13 |
| Last modified on | 2021/02/11 09:57:17 |
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Basic information
Public title
The effect of intravitreal injection of ranibizumab before direct photocoagulation in the treatment of focal diabetic macular edema
Acronym
Ranibizumab treatment with lasers for focal DME
Scientific Title
The effect of intravitreal injection of ranibizumab before direct photocoagulation in the treatment of focal diabetic macular edema
Scientific Title:Acronym
Ranibizumab treatment with lasers for focal DME
Region
| Japan |
Condition
Condition
diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of intravitreal injection of ranibizumab for the treatment of diabetic macular edema.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
retinal thickness, visual acuity,
Key secondary outcomes
THe frequency of additional treatment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with type 1 or type 2 diabetes mellitus 20 years of age or older.
Patients with fovea involving diabetic macular edema (judged with central subfield thickness on OCT).
Patients with reduced visual acuity associated with diabetic macular edema.
Patients with a central retinal thickness (CRT) of 300 um or more on the OCT retinal map (measured in mm) as an objective finding.
Patients who are willing and able to visit the study site, as scheduled, and undergo scheduled examinations in this study
Patients who can provide written voluntary consent to participate in this study after receiving adequate explanation.
Key exclusion criteria
A history of any intraocular surgery in the study eye within the previous 90 days
It is considered difficult to improve visual acuity due to morphological changes
Glaucoma with poor IOP control, a history of glaucoma filtering surgery, or scheduled filtering surgery in the study eye
IOP of the study eye: more than 25 mmHg
Myopia of -8D or greater
Optic media in which it is difficult to obtain fundus photographs or OCT images
Severe systemic infections at baseline
Systemic anticoagulation therapy within 180
Poorly controlled diabetes mellitus
Poorly controlled hypertension
A history of cerebrovascular accident and/or myocardial infarction within 180 days
Patients on dialysis and patients with renal failure requiring dialysis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Takamura |
Organization
University of Fukui
Division name
Ophthalmology
Zip code
910-1193
Address
23-3 Shimoaizuki Matsuoka Yoshida Fukui
TEL
0776618403
takamurayoshihiro@gmail.com
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Takamura |
Organization
University of Fukui
Division name
Ophthalmology
Zip code
910-1193
Address
23-3 Shimoaizuki Matsuoka Yoshida Fukui
TEL
0776618403
Homepage URL
takamurayoshihiro@gmail.com
Sponsor or person
Institute
University of Fukui, Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
University of Fukui, Ophthalmology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
2
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Fukui
Address
23-3 Shimoaizuki Matsuoka Yoshida Fukui
Tel
0776-61-8403
takamurayoshihiro@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 02 | Month | 10 | Day |
Last modified on
| 2021 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040816
