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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name