UMIN-CTR Clinical Trial

Basic information
Public title	The evaluation of treatment effect for age-related macular degeneration by using aflibercept preferentially in Yamaguchi University.
Acronym	The evaluation of treatment effect for age-related macular degeneration by using aflibercept preferentially in Yamaguchi University.
Scientific Title	The evaluation of treatment effect for age-related macular degeneration by using aflibercept preferentially in Yamaguchi University.
Scientific Title:Acronym	The evaluation of treatment effect for age-related macular degeneration by using aflibercept preferentially in Yamaguchi University.
Region	Japan

Condition
Condition	age-related macular degeneration
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In the treatment of anti-vascular endothelial growth factor (VEGF) agents injection for age-related macular degeneration (AMD), patients are needed for prolonged repeated treatment for the recurrence exudation to maintenance of visual acuity, and physical, psychological and economic burden of patients become problem. The recurrence intervals of AMD are differ in individuals, so it is be considered that the retreatment intervals of anti-VEGF agents injection had better to be adjusted to provide the needed performance with minimum injections. So we considered that more individualized retreatment regimen could be these alleviate a burden on patients. In this study, we evaluated retrospectively the treatment effect and interval of intravitreal aflibercept injection preferentially for untreated AMD in Yamaguchi University Hospital.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of visual acuity at 2nd year after starting treatment
Key secondary outcomes	The treatment interval of aflibercept at 2nd year after starting treatment

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Untreated age-related macular degeneration patients started the treatment of aflibercept injection during study period
Key exclusion criteria	1) The patient who had a history of treatment using anti-VEGF agents, 2) The patient who entry to other intervention study
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Kazuhiro Middle name Last name Kimura
Organization	Yamaguchi University graduate school of medicine
Division name	Department of Ophthalmology
Zip code	755-0032
Address	1-1-1 Minami Kogushi, Ube city, Yamaguchi, Japan
TEL	0836-22-2278
Email	k.kimura@yamaguchi-u.ac.jp

Public contact
Name of contact person	1st name Makiko Middle name Last name Wakuta
Organization	Yamaguchi University graduate school of medicine
Division name	Department of Ophthalmology
Zip code	755-0032
Address	1-1-1 Minami Kogushi, Ube city, Yamaguchi, Japan
TEL	0836-22-2278
Homepage URL
Email	mwakut@yamaguchi-u.ac.jp

Sponsor
Institute	Department of Ophthalmology Yamaguchi University graduate school of medicine
Institute
Department

Funding Source
Organization	Department of Ophthalmology Yamaguchi University graduate school of medicine
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	Center For Clinical Research, Yamaguchi University Hospital
Address	1-1-1 Minami Kogushi, Ube city, Yamaguchi, Japan
Tel	0836-22-2428
Email	me223@yamaguchi-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	2019 Year 10 Month 21 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	73
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	Completed
Date of protocol fixation	2013 Year 08 Month 01 Day
Date of IRB	2017 Year 10 Month 27 Day
Anticipated trial start date	2013 Year 08 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other

Other related information

Retrospective observational study without intervention. Treatment naive exdative age-related macular degeneration patients using aflibercept injetion from 1st/Aug./2013 to 31th/Jul./2017 in Yamaguchi University Hospital. extracted items; gender, birth year/month, diagnosis, the date of first treatment, used drug, adverse events, treatment history, current medical history, examination findings of the eye, visual acuity, intraocular pressure, the findings of fluorescein and indocyanine green angiography, optical coherence tomography, color fundus photograph

Management information
Registered date	2019 Year 10 Month 18 Day
Last modified on	2021 Year 04 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043640