UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Long term outcomes of intravitreous aflibercept injections for agerelated macular degeneration
Title of the study (Brief title)	Long term outcomes of IAI for AMD
Region	Japan

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

Objectives
Narrative objectives1	To examine the long-term effect of intravitreal aflibercept injection for eyes with age-related macular degeneration.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Best corrected visual acuity, retinal structure, choroidal structure, and adverse event.
Key secondary outcomes	Number of IAI.

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	Patients who diagnosed wet AMD.
Key exclusion criteria	Patients who diagnosed central serous chorioretinopathy CSC or any other vitreo-retinal diseases.
Target sample size	120

Research contact person
Name of lead principal investigator	Yasuki Ito
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Ophthalmology Protective care for Sensory Disorders
Address	65 Tsurumai-cho, Showa-ku, Nagoya City
TEL	052-744-2275
Email	yasu@med.nagoya-u.ac.jp

Public contact
Name of contact person	Kei Takayama
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Ophthalmology Protective care for Sensory Disorders
Address	65 Tsurumai-cho, Showa-ku, Nagoya City
TEL	052-744-2275
Homepage URL
Email	keitaka1234@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Ophthalmology Protective care for Sensory Disorders, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2016 Year 10 Month 15 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 12 Month 01 Day
Anticipated trial start date	2012 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	We compared outcomes of IAI for eyes with naive wet AMD visiting Nagoya University Hospital, Nagoya city, Japan for the first time between December 2012 to December 2015 and contunuing follow-up treatment were enrolled. The changes of visual acuity, retinal structure, choroidal structure, focal macular electroretinogram, and number of injection were compared.

Management information
Registered date	2016 Year 10 Month 15 Day
Last modified on	2016 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028106