UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044356 |
|---|---|
| Receipt number | R000050659 |
| Scientific Title | The effect of brolucizumab on age-related macular degeneration |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2021/05/28 12:38:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of brolucizumab on age-related macular degeneration
Acronym
The effect of brolucizumab on AMD
Scientific Title
The effect of brolucizumab on age-related macular degeneration
Scientific Title:Acronym
The effect of brolucizumab on AMD
Region
| Japan |
Condition
Condition
Age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Age-related macular degeneration (AMD) causes the reduction of vision and quality of life. Currently, there is no curative treatment, but in 2020, a new treatment for AMD, brolucizumab, was approved in Japan. The purpose of this study is to evaluate the effect of brolucizumab on AMD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
This observational study is planned for 2 years after administration of brolucizumab. An interim evaluation will be made one year after the administration.
The main outcome are visual acuity and the retinal status.
Key secondary outcomes
The required number of brolucizumab administration during the observation period.
Background factors (age, gender, classification of AMD, past history, and lifestyle) effect on thetherapeutic effect of brolucizumab.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects are patients diagnosed with wet-age-related macular degeneration.
Subjects aged 20 years or older at the time of informed consent.
Subjects who received sufficient informed consent before participating in this study, and after sufficient understanding, obtained the voluntary written consent of the subjects themselves.
There is no target number of recruitment by gender.
Key exclusion criteria
Those who are judged by the principal investigator to be inappropriate as research subjects.
Those who are judged to have difficulty in going to the hospital on a regular basis.
Those who have an intra-ocular inflammation.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hirakata |
| Middle name | |
| Last name | Toshiaki |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Ophthalmology
Zip code
113-8421
Address
Hongo 3-1-3. Bunkyo-ku, Tokyo
TEL
0338133111
t-hirakata@juntndo.ac.jp
Public contact
Name of contact person
| 1st name | Hirakata |
| Middle name | |
| Last name | Toshiaki |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Ophthalmology
Zip code
113-8421
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo, Japan
TEL
0338133111
Homepage URL
t-hirakata@juntendo.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Institutional Review Board at Juntendo University Hospital
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo
Tel
0338133111
jun-rinri@juntendo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
20-168
Org. issuing International ID_1
Institutional Review Board at Juntendo University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study design is a prospective study of wet-AMD patients treated with brolucizumab.
Management information
Registered date
| 2021 | Year | 05 | Month | 28 | Day |
Last modified on
| 2021 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050659
