UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063577 |
|---|---|
| Receipt number | R000072755 |
| Scientific Title | GA secondary to AMD with or without izervay treatment study |
| Date of disclosure of the study information | 2026/11/13 |
| Last modified on | 2026/11/10 11:08:51 |
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Basic information
Public title
Real-world clinical data of geographic atrophy with or without treatments with avacincaptad pegol in Japan
Acronym
GA secondary to AMD with or without izervay treatment study
Scientific Title
GA secondary to AMD with or without izervay treatment study
Scientific Title:Acronym
GAIT study
Region
| Japan |
Condition
Condition
age-related macular degeneration with geographic atrophy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We analyze clinical courses of the patients diagnosed with age-related macular degeneration with geographic atrophy with or without izervay treatment and show the safety and efficacy of the treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the area of atrophic lesion
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who exhibit geographic atrophy secondary to age-related macular degeneration
Key exclusion criteria
1.Those who do not agree to participate the study
2.Those whoes data are not clear
3.Those who exhibit atrophic lesions due to pathologic myopia or inherited retinal diseases
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Ozawa |
Organization
Fujita Medical Innovation Center, Tokyo
Division name
Eye Center, Fujita Health University Haneda clinic
Zip code
144-0041
Address
1-1-4, Hanedakuko, Otaku, Tokyo
TEL
0357087830
yoko.ozawa@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Ozawa |
Organization
Fujita Medical Innovation Center, Tokyo
Division name
Eye Center, Fujita Health University Haneda clinic
Zip code
144-0041
Address
1-1-4, Hanedakuko, Otaku, Tokyo
TEL
0357087830
Homepage URL
yoko.ozawa@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Medical Innovation Center, Tokyo
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Medical Innovation Center, Tokyo
Address
1-1-4, Hanedakuko, Otaku, Tokyo
Tel
0357087830
yoko.ozawa@fujita-hu.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 | 11 | Month | 13 | 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
| 2026 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NONE
Management information
Registered date
| 2026 | Year | 11 | Month | 10 | Day |
Last modified on
| 2026 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072755
