UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041382 |
|---|---|
| Receipt number | R000046978 |
| Scientific Title | Examination of therapeutic efficacy after changing brolucizumab for patients with wet age-related macular degeneration using existing anti-VEGF drugs. |
| Date of disclosure of the study information | 2020/08/11 |
| Last modified on | 2022/02/22 20:12:34 |
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Basic information
Public title
Examination of therapeutic efficacy after changing brolucizumab for patients with wet age-related macular degeneration using existing anti-VEGF drugs.
Acronym
Efficacy of treatment after changing brolucizumab for wet AMD
Scientific Title
Examination of therapeutic efficacy after changing brolucizumab for patients with wet age-related macular degeneration using existing anti-VEGF drugs.
Scientific Title:Acronym
Efficacy of treatment after changing brolucizumab for wet AMD
Region
| Japan |
Condition
Condition
wet age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical efficacy of brolucizumab for patients with wet age-related macular degeneration existing anti-VEGF drugs.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement rate of visual acuity one year after the change of brolucizumab.
Key secondary outcomes
One year outcome after the change of brolcizumab:macula dry rate(presence of absence of exudative change), reduction rate of central macular thickness, change rate of subfoveal choroidal thickness, the rate of incidence and enlargement of macular atrophy, and number of administrations
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
Intravitreous injection of Beovu(Brolucizumab) for 2 years when needed.
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
3)disease duration:regardless
4)Patients who existing anti-VEGF drugs (aflibercept or ranibizumabu) are used, and vitreous injections are performed every 1-3months in the maintenance phase, and exudation dose not improve for 1 year or more(tolerance), who progress vision loss, who relapses immediately without without injection (dependency), and who do not respond to existing anti-VEGF drug therapy from the initial treatment (non responder).
5)BCVA:0.1-1.0
6)Presence of subretinal hemorrhage, scar or macular fibrosis (<50% lesion area)
7)Patient consent:patients who, after receiving a sufficient explanation before participating in this study, obtained their informed consent by themselves.
8)Outpatien
Key exclusion criteria
1) Greatest Linear Dimension (GLD) of the total lesion area <12 Macular Photocoagulation Study Disc Areas
2) Presence of subretinal hemorrhage, scar or macular fibrosis (>50% lesion area)
3) Prior treatment with dexamethasone (<6 months) or triamcinolone (<30 days), intraocular surgery (<3 months)
4) Active intraocular inflammation
5) Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products
6) Patient who the doctor in charge judges are ineligible for the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Suzuma |
Organization
Kagawa Medical University Hospital
Division name
ophthalmology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture
TEL
087-898-5111
hkojima721@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Kojima |
Organization
Kagawa Medical University Hospital
Division name
ophthalmology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture
TEL
087-898-5111
Homepage URL
hkojima721@med.kagawa-u.ac.jp
Sponsor or person
Institute
kagawa university
Institute
Department
Personal name
Funding Source
Organization
Kagawa university
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
Clinical Research Support Center, Kagawa University Hospital
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture
Tel
087-898-5111
chiken@med.kagawa-u.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
| 2020 | Year | 08 | Month | 11 | 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
| 2020 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 07 | 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
| 2020 | Year | 08 | Month | 11 | Day |
Last modified on
| 2022 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046978
