UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059703 |
|---|---|
| Receipt number | R000068286 |
| Scientific Title | Efficacy of brolucizumab for diabetic macular edema and identification of treatment-resistant factors |
| Date of disclosure of the study information | 2025/11/08 |
| Last modified on | 2025/11/08 20:44:26 |
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Basic information
Public title
Efficacy of brolucizumab for diabetic macular edema and identification of treatment-resistant factors
Acronym
Efficacy of brolucizumab for diabetic macular edema and identification of treatment-resistant factors
Scientific Title
Efficacy of brolucizumab for diabetic macular edema and identification of treatment-resistant factors
Scientific Title:Acronym
Efficacy of brolucizumab for diabetic macular edema and identification of treatment-resistant factors
Region
| Japan |
Condition
Condition
Diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the treat-and-extend regimen with brolucizumab in diabetic macular edema. Additionally, to analyze various laboratory data, imaging data, and intraocular cytokines to investigate factors contributing to treatment resistance and discontinuation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in best corrected visual acuity (BCVA)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Brolucizumab intravitreal injection
Aqueous humor collection
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
1) Patients diagnosed with DME (regardless of severity)
2) Patients aged 20 years or older (regardless of gender)
3) Patients with untreated DME
4) Outpatients
5) Patients who have provided written informed consent to participate in this study
6) Patients with baseline corrected visual acuity between 0.8 and 0.05
7) Patients who selected the brolucizumab treat and extend regimen
Key exclusion criteria
1) Active intraocular or periorbital infection; history of idiopathic/autoimmune uveitis
2) Cases suspected of having a history of retinal vasculitis/occlusive retinal vasculitis
3) Neovascular glaucoma
4) Cerebral infarction/myocardial infarction within the past 6 months
5) Undergoing dialysis
6) Severe hypersensitivity to fluorescein or iodine
7) Patients deemed unsuitable for the study at the physician's discretion
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Akiyama |
Organization
Gunma University
Division name
Ophthalmology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi-shi, Gunma
TEL
027-220-8338
akiyamah47@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuma |
| Middle name | |
| Last name | Saito |
Organization
Gunma University
Division name
Ophthalmology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi-shi, Gunma
TEL
027-220-8338
Homepage URL
kazuma3110@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi, Maebashi-shi, Gunma
Tel
027-220-8740
gunmaciru-office@umin.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
| 2025 | Year | 11 | Month | 08 | 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
| 2025 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2031 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 08 | Day |
Last modified on
| 2025 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068286
