UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049461 |
|---|---|
| Receipt number | R000056312 |
| Scientific Title | Intraocular Inflammation following Intravitreal Brolucizumab for Neovascular Age-Related Macular Degeneration in Japanese Patients: Meta analysis using individual patient data |
| Date of disclosure of the study information | 2022/11/08 |
| Last modified on | 2023/11/20 13:29:02 |
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Basic information
Public title
Intraocular Inflammation following Intravitreal Brolucizumab for Neovascular Age-Related Macular Degeneration in Japanese Patients: Meta analysis using individual patient data
Acronym
Individual data analysis of Intraocular Inflammation following Intravitreal Brolucizumab
Scientific Title
Intraocular Inflammation following Intravitreal Brolucizumab for Neovascular Age-Related Macular Degeneration in Japanese Patients: Meta analysis using individual patient data
Scientific Title:Acronym
Individual data analysis of Intraocular Inflammation following Intravitreal Brolucizumab
Region
| Japan |
Condition
Condition
nAMD
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of intraocular inflammation (IOI) and its risk factors following intravitreal brolucizumab (IVBr) for neovascular age-related macular degeneration (nAMD) using a large multicenter data set.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk factors of IOI following IVBr
(gender, age, the number of IVBr before IOI onset, history of smoking, HT, DM, RV/RO and the treatment of nAMD)
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
Subjects were Japanese nAMD patients who treated with IVBr for nAMD at least one time.
Key exclusion criteria
Patients were excluded if he/she had a prophylactic treatment(s) for IOI, including topical administration of steroids
Target sample size
1080
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Takahashi |
Organization
Jichi Medical University
Division name
Ophthalmology
Zip code
3290498
Address
Yakushiji 3311-1, Shimotsuke, Tochigi.
TEL
0285-58-7382
takahah-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Inoda |
Organization
Jichi Medical University
Division name
Ophthalmology
Zip code
3290498
Address
Yakushiji 3311-1, Shimotsuke, Tochigi.
TEL
0285-58-7382
Homepage URL
r1208is@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
non
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
Jichi Medical University Clinical Research Ethics Committee
Address
Yakushiji 3311-1, Shimotsuke, Tochigi.
Tel
0285-58-8933
nintei-rinri@jichi.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
大阪市立大学(大阪府)、 関西医科大学（大阪府），杏林大学（東京都）、群馬大学（群馬県）、神戸大学（兵庫県）、帝京大学(東京都)、東京女子医科大学（東京都）、富山大学 （富山県）、名古屋大学 （愛知県）、日本大学病院（東京都）、福島県立医科大学 （福島県）、横浜市立大学 視覚再生外科 （神奈川県）、琉球大学（沖縄県）、西葛西井上眼科病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | 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
1351
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
Main results already published
Date of protocol fixation
| 2022 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 10 | Month | 21 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 21 | Day |
Other
Other related information
non
Management information
Registered date
| 2022 | Year | 11 | Month | 08 | Day |
Last modified on
| 2023 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056312
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| Registered date | File name |
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