UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050071 |
|---|---|
| Receipt number | R000056928 |
| Scientific Title | Flare levels after intravitreal injection of Brolucizumab for diabetic macular edema Joint prospective observational study |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2023/01/18 14:59:08 |
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Basic information
Public title
Flare levels after intravitreal injection of Brolucizumab for diabetic macular edema
Acronym
Flare levels after Brolucizumab for diabetic macular edema
Scientific Title
Flare levels after intravitreal injection of Brolucizumab for diabetic macular edema
Joint prospective observational study
Scientific Title:Acronym
Flare levels after Brolucizumab for diabetic macular edema
Region
| Japan |
Condition
Condition
diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By measuring intracameral flare intensity and central retinal thickness before and after intravitreal injection of brolucizumab in patients with diabetic macular edema, we will investigate changes in inflammation due to intravitreal injection and its effects on the disease progression of diabetic macular edema. Diabetic macular edema has many cases with inflammatory findings, and changes in inflammation due to brolucizumab administration may be useful in assessing therapeutic effects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Flare levels
before administration of brolucizumab, 1 week after the first administration, 6 weeks after the first administration, and every 6 weeks after the second injection until the end of the induction period.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a diagnosis of diabetic macular edema
Patients who started treatment with brolucizumab
Key exclusion criteria
Patients with hypersensitivity to drugs such as allergies
Pregnant women, patients who may be pregnant, breastfeeding patients, and those who wish to become pregnant while in a research institution
Patients who have participated in other clinical studies within 4 months
Other patients who are judged by the principal investigator to be unsuitable as research subjects
Patients with or suspected infection in or around the eye
Patients with active intraocular inflammation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Inatani |
Organization
Fukui university
Division name
Ophthalmology
Zip code
910-1193
Address
23-3 Shimoaizuki Matsuoka, Eiheiji Town, Yoshida District, Fukui Prefecture
TEL
0776-61-3111
fganka@med.u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Yushi |
| Middle name | |
| Last name | Ichihashi |
Organization
Fukui university
Division name
Ophthalmology
Zip code
910-1193
Address
23-3 Shimoaizuki Matsuoka, Eiheiji Town, Yoshida District, Fukui Prefecture
TEL
0776-61-3111
Homepage URL
fganka@med.u-fukui.ac.jp
Sponsor or person
Institute
Fukui university
Institute
Department
Personal name
Funding Source
Organization
No organization
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
Fukui university
Address
23-3 Shimoaizuki Matsuoka, Eiheiji Town, Yoshida District, Fukui Prefecture
Tel
0776-61-3111
fganka@med.u-fukui.ac.jp
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
| 2023 | Year | 02 | Month | 01 | 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
| 2022 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To measure the intracameral flare intensity in patients treated with brolucizumab for diabetic macular edema.
Management information
Registered date
| 2023 | Year | 01 | Month | 18 | Day |
Last modified on
| 2023 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056928
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
