UMIN-CTR Clinical Trial

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
Institute	kagawa univercity
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046988