UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044374
Receipt number R000050688
Scientific Title A prospective study examining the effect of brolcizumab on neovascular age-related macular degeneration in Japanese with treat and extend
Date of disclosure of the study information 2021/05/31
Last modified on 2023/11/20 13:27:44

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Basic information

Public title

A study examining the effect of the brolcizumab
on neovascular age-related macular degeneration in Japanese with treat and extend

Acronym

brolcizumab on nAMD in Japanese with treat and extend

Scientific Title

A prospective study examining the effect of brolcizumab on neovascular age-related macular degeneration in Japanese with treat and extend

Scientific Title:Acronym

A prospective stud ; brolcizumab on nAMD in Japanese with treat and extend

Region

Japan


Condition

Condition

neovascular age-related macular degeneration

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the efficacy and safety of brolcizumab on neovascylar age-related macular degeneration in Japanese.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Percentage of patients with visual acuity and dosing interval extended to 12 weeks after 12 or 24 months

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

89 years-old >

Gender

Male and Female

Key inclusion criteria

choroidal neovascularization due to exudative age-related macular degeneration is confirmed by FA/IA within 3000 micro meter centered on the fovea centralis.
Visual acuity is reduced due to exudative changes in the macula.
Within 6 months of onset
There is consent for this research
Untreated

Key exclusion criteria

Eye surgery within 3 months
There are other disorders that cause vision loss
History of vitreous surgery
History of grid-like photocoagulation
History of cerebrocardiovascular events within 6 months
Adults who are judged to lack informed consent
Doctor judges that it is not suitable for this study

Target sample size

50


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

Tochigi, Shimotsuke city Yakushiji 3311-1

TEL

0285587382

Email

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

Tochigi, Shimotsuke city Yakushiji 3311-1

TEL

0285587382

Homepage URL


Email

r1208is@jichi.ac.jp


Sponsor or person

Institute

Jichi Medical University

Institute

Department

Personal name



Funding Source

Organization

Jichi Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Haga Japanese Red Cross Hospital
Sano City Hospital, Sano-shi

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Jichi Medical University Clinical Research Ethics Committee

Address

Tochi Shimotsuke Yakashiji 3311-1

Tel

0285-58-8933

Email

jrinri@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



Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 31 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

50

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

Completed

Date of protocol fixation

2020 Year 10 Month 10 Day

Date of IRB

2020 Year 11 Month 06 Day

Anticipated trial start date

2020 Year 11 Month 06 Day

Last follow-up date

2023 Year 09 Month 30 Day

Date of closure to data entry

2023 Year 10 Month 20 Day

Date trial data considered complete

2023 Year 10 Month 20 Day

Date analysis concluded

2023 Year 10 Month 20 Day


Other

Other related information

Gender, age, pre-treatment and up to 24 months after treatment, visual acuity, fundus photograph, optical coherence tomography, maximum corrected visual acuity, retinal film thickness, and number of consultations. In addition, as a type of wet age-related macular degeneration, typical AMD, polypoid choroidal angiopathy, diagnostic classification of retinal hemangiomatous growth, and frequency of vitreous injection administration


Management information

Registered date

2021 Year 05 Month 30 Day

Last modified on

2023 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050688


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name