UMIN-CTR Clinical Trial

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
Email	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
Email	t-hirakata@juntendo.ac.jp

Sponsor
Institute	Department of Ophthalmology, Juntendo University Faculty of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050659