UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061506 |
|---|---|
| Receipt number | R000070382 |
| Scientific Title | Comparison of Adverse Events Between Fluorescein Angiography Alone and Combined Fluorescein and Indocyanine Green Angiography |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/10 15:33:08 |
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Basic information
Public title
Study of Adverse Events in Fluorescein Angiography Examinations
Acronym
FA-AE Study
Scientific Title
Comparison of Adverse Events Between Fluorescein Angiography Alone and Combined Fluorescein and Indocyanine Green Angiography
Scientific Title:Acronym
FAvsFA+ICGA Study
Region
| Japan |
Condition
Condition
Patients undergoing fluorescein angiography for retinal and choroidal diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the incidence and characteristics of adverse events between fluorescein angiography (FA) alone and combined fluorescein and indocyanine green angiography (FA+ICGA), and to evaluate the safety of angiographic examinations.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of adverse events in the FA alone group and the combined FA+ICGA group
Key secondary outcomes
Rate of examination discontinuation or inability to complete examination
Frequency of each type of adverse event
Clinical characteristics of patients with discontinued or incomplete examinations
Rate of repeat angiographic examinations after adverse events
Recurrence rate of adverse events
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 underwent fluorescein angiography examinations at Nagoya University Hospital between October 1, 2014 and November 18, 2025
Patients whose examination records and adverse event information are available in the electronic medical records and examination logs
Key exclusion criteria
Cases in which angiographic examination could not be confirmed from examination records
Cases undergoing ICGA alone
Target sample size
10000
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, Aichi 466-8560, Japan
TEL
052-744-2277
takeuchi.jun@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Taishi |
| Middle name | |
| Last name | Imao |
Organization
Nagoya University Hospital
Division name
Department of Ophthalmology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560, Japan
TEL
052-744-2277
Homepage URL
imao.taishi.y0@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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
Nagoya University Graduate School of Medicine Ethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560, Japan
Tel
052-744-2479
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
| 2026 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center retrospective observational study using existing clinical data without additional intervention.
Management information
Registered date
| 2026 | Year | 05 | Month | 10 | Day |
Last modified on
| 2026 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070382
