UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041389
Receipt number R000046988
Scientific Title A 2-year study comparing the efficacy and safety of anti-VEGF drugs (aflibercept and brolucizumab) in patients with exudative age-related macular degeneration.
Date of disclosure of the study information 2020/08/12
Last modified on 2020/09/28 22:04:22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A 2-year study comparing the efficacy and safety of anti-VEGF drugs (aflibercept and brolucizumab) in patients with exudative age-related macular degeneration.

Acronym

Efficacy of anti-VEGF drugs (aflibercept and brolucizumab) against wAMD

Scientific Title

A 2-year study comparing the efficacy and safety of anti-VEGF drugs (aflibercept and brolucizumab) in patients with exudative age-related macular degeneration.

Scientific Title:Acronym

Efficacy of anti-VEGF drugs (aflibercept and brolucizumab) against wAMD

Region

Japan


Condition

Condition

wet age-related macular degeneration

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy and safety of anti-VEGF drugs (aflibercept and brolucizumab) in patients with wet age-related macular degeneration with subfoveal choroidal neovascularization (CNV).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Amount of change in visual acuity at 52 weeks

Key secondary outcomes

The average treatment number according to the medicine , central macular thickness, change of leakage in retinal region, leakage from a polyp, leakage from choroidal neovascularization, subretinal fluid , the rate of incident and the enlargement of the geographic atrophy


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Eylea (aflibercept)

Interventions/Control_2

Beovu(brolucizmab)

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

1) BCVA: 0.1-1.0
2) AMD with subfoveal fluid on fluorescent angiography, indocyanine green angiography and/or optical coherence tomography
3) Willingness to provide written informed consent
4) outpatient

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 anti-VEGF drug, photodynamic therapy
4) Prior treatment with dexamethasone (<6 months) or triamcinolone (<30 days), intraocular surgery (<3 months)
5) Active intraocular inflammation
6) Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products
7) Patient who the doctor in charge judges are ineligible for the study

Target sample size

140


Research contact person

Name of lead principal investigator

1st name chieko
Middle name
Last name shiragami

Organization

kagawa university hospital

Division name

Ophthalmology

Zip code

761-0793

Address

1750-1, ikenobe, mikicho, kitagun, kagawa

TEL

0878912211

Email

chappi@med.kagawa-u.ac.jp


Public contact

Name of contact person

1st name yukiko
Middle name
Last name miyoshi

Organization

kagawa university hospital

Division name

Ophthalmology

Zip code

761-0793

Address

1750-1, ikenobe, mikicho, kidagun, kagawa

TEL

0878912211

Homepage URL


Email

yukiko-m@med.kagawa-u.ac.jp


Sponsor or person

Institute

kagawa univercity

Institute

Department

Personal name



Funding Source

Organization

nothing

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

kagawa university hospital

Address

1750-1, ikenobe, mikicho, kitagun, kagawa

Tel

0878912211

Email

yukiko-m@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 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

Preinitiation

Date of protocol fixation

2020 Year 07 Month 20 Day

Date of IRB


Anticipated trial start date

2020 Year 07 Month 20 Day

Last follow-up date

2024 Year 08 Month 31 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

2020 Year 09 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046988


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name