UMIN-CTR Clinical Trial

Basic information
Public title	Retinal Sensitivity Study in the Fellow Eye in Age-Related Macular Degeneration in Japan
Acronym	Study in the Fellow Eye in Age-Related Macular Degeneration in Japan
Scientific Title	Five-Year Follow-Up of Fundus Autofluorescence and Retinal Sensitivity in the Fellow Eye in Age-Related Macular Degeneration in Japan
Scientific Title:Acronym	The Fellow Eye in Age-Related Macular Degeneration in Japan
Region	Japan

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

Objectives
Narrative objectives1	To assess abnormal fundus autofluorescence (FAF) and retinal sensitivity in the fellow eye of Japanese patients with unilateral neovascular age-related macular degeneration (AMD).
Basic objectives2	Others
Basic objectives -Others	The 5-year study.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The association between microperimetry and FAF imaging.
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	The eligible patients were Japanese, aged over 50 years, and had unilateral neovascular AMD. The inclusion criterion was hyper- or hypofluorescence on FAF imaging in the fellow eye in unilateral neovascular AMD.
Key exclusion criteria	The major exclusion criteria were the presence of exudative findings, including CNV, hemorrhage, serous RPE detachment, serous retinal detachment, and hard exudates, diabetic retinopathy, uveitis, high myopia (less than minus 8.0 diopters), retinal vein occlusion, hazy media interfering with fundus examinations, or a history of laser photocoagulation.
Target sample size	67

Research contact person
Name of lead principal investigator	1st name Tsutomu Middle name Last name Yasukawa
Organization	Nagoya City University School of Medicine
Division name	Department of Ophthalmology and Visual Sciences
Zip code	467-8601
Address	Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL	+81-52-853-8251
Email	yasukawa@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Tsutomu Middle name Last name Yasukawa
Organization	Nagoya City University School of Medicine
Division name	Department of Ophthalmology and Visual Sciences
Zip code	467-8601
Address	Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL	+81-52-853-8251
Homepage URL
Email	yasukawa@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University School of Medicine
Institute
Department

Funding Source
Organization	JSPS
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Santen Pharmaceutical Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya City University School of Medicine
Address	Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan
Tel	+81-52-853-8251
Email	yasukawa@med.nagoya-cu.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	名古屋市立大学病院、九州大学病院、駿河台日本大学病院、福島県立医大病院

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 22 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	67
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	2006 Year 11 Month 30 Day
Date of IRB	2006 Year 11 Month 30 Day
Anticipated trial start date	2006 Year 12 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2019 Year 09 Month 19 Day
Last modified on	2019 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043372