UMIN-CTR Clinical Trial

Basic information
Public title	Switching from existing anti-VEGF agents to ranibizumab BS in age-related macular degeneration
Acronym	Switching from existing anti-VEGF agents to ranibizumab BS in AMD
Scientific Title	Switching from existing anti-VEGF agents to ranibizumab BS in age-related macular degeneration
Scientific Title:Acronym	Switching from existing anti-VEGF agents to ranibizumab BS in AMD
Region	Japan

Condition
Condition	Age-Related Macular Degeneration
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is aimed to examine changes in the frequency of drug administration directly related to the patient treatment burden in AMD eyes that have been switched from existing anti-VEGF drugs to ranibizumab BS.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Interval/frequency of anti-VEGF agents during the follow-up period
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient with AMD who has been treated with existing anti-VEGF agents using the Treat and Extend (TAE) regimen for more than one year and who has decided to switch to ranibizumab BS at the patient's request.
Key exclusion criteria	Patients with unstable drug administration intervals with TAE regimen using existing anti-VEGF drugs, patients with other concomitant ocular diseases such as active uveitis and proliferative diabetic retinopathy, patients who have undergone previous vitrectomy or treatment with unknown details at other hospitals, and patients for whom anterior chamber fluid sampling by anterior chamber puncture is deemed unsafe.
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Kaneko
Organization	Nagoya university hospital
Division name	Department of Ophthalmology
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2275
Email	h-kaneko@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	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2275
Homepage URL
Email	takeuchi.jun@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya university
Institute
Department

Funding Source
Organization	Senju Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee
Address	65 Tsurumai-cho, Showa-ku, Nagoya
Tel	052-744-2479
Email	ethics@med.nagoya-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	2022 Year 07 Month 18 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	Enrolling by invitation
Date of protocol fixation	2022 Year 07 Month 14 Day
Date of IRB	2022 Year 06 Month 29 Day
Anticipated trial start date	2022 Year 07 Month 14 Day
Last follow-up date	2025 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2022 Year 07 Month 17 Day
Last modified on	2022 Year 08 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055163