UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044180 |
|---|---|
| Receipt number | R000050454 |
| Scientific Title | Efficacy of brolucizumab on AMD in patients exhibiting aflibercept resistance |
| Date of disclosure of the study information | 2021/05/12 |
| Last modified on | 2021/05/12 02:21:08 |
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Basic information
Public title
Efficacy of brolucizumab on AMD in patients exhibiting
aflibercept resistance
Acronym
AMD treated by anti-VEGF drugs
Scientific Title
Efficacy of brolucizumab on AMD in patients exhibiting
aflibercept resistance
Scientific Title:Acronym
AMD treated by anti-VEGF drugs
Region
| Japan |
Condition
Condition
AMD
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine outcomes of the switch to brolucizumab in neovascular age-related macular degeneration (nAMD) refractory to aflibercept.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sex, age, visual acuity, visual field, refraction, corneal curvature radius, corneal thickness, ocular axial length, fundus observation,Optical coherence tomography, optical coherence tomography angiography, fundus photograph, fluorescence fundus angiography, slit lamp microscopy, duration of disease, current medical history, past history, family history, medication used, frequency of dosing
Key secondary outcomes
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with nAMD switched from aflibercept to brolucizumab between June 2020 to December 2020 at Nagoya University Hospital.
Key exclusion criteria
nothing special
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Takeuchi |
Organization
Nagoya University Hospital
Division name
Department of Ophthalmology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2275
takeuchi.jun@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | jun |
| Middle name | |
| Last name | Takeuchi |
Organization
Nagoya University Hospital
Division name
Department of Ophthalmology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2275
Homepage URL
takeuchi.jun@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya 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
Medical Research and Clinical Ethics Promotion Office
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
0527442423
iga-shinsa@adm.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Nagoya University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 12 | 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 | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing special
Management information
Registered date
| 2021 | Year | 05 | Month | 12 | Day |
Last modified on
| 2021 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050454
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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