UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of brolucizumab on AMD in patients exhibiting aflibercept resistance
Acronym	AMD treated by anti-VEGF drugs
Scientific Title	Efficacy of brolucizumab on AMD in patients exhibiting aflibercept resistance
Scientific Title:Acronym	AMD treated by anti-VEGF drugs
Region	Japan

Condition
Condition	AMD
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine outcomes of the switch to brolucizumab in neovascular age-related macular degeneration (nAMD) refractory to aflibercept.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sex, age, visual acuity, visual field, refraction, corneal curvature radius, corneal thickness, ocular axial length, fundus observation,Optical coherence tomography, optical coherence tomography angiography, fundus photograph, fluorescence fundus angiography, slit lamp microscopy, duration of disease, current medical history, past history, family history, medication used, frequency of dosing
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with nAMD switched from aflibercept to brolucizumab between June 2020 to December 2020 at Nagoya University Hospital.
Key exclusion criteria	nothing special
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Takeuchi
Organization	Nagoya University Hospital
Division name	Department of Ophthalmology
Zip code	466-8560
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2275
Email	takeuchi.jun@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name jun Middle name Last name Takeuchi
Organization	Nagoya University Hospital
Division name	Department of Ophthalmology
Zip code	466-8560
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2275
Homepage URL
Email	takeuchi.jun@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Nagoya 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	Medical Research and Clinical Ethics Promotion Office
Address	65 Tsurumai-cho, Showa-ku, Nagoya
Tel	0527442423
Email	iga-shinsa@adm.nagoya-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1	Nagoya University
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 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	Open public recruiting
Date of protocol fixation	2020 Year 06 Month 01 Day
Date of IRB	2021 Year 05 Month 13 Day
Anticipated trial start date	2020 Year 06 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing special

Management information
Registered date	2021 Year 05 Month 12 Day
Last modified on	2021 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050454