UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062498 |
|---|---|
| Receipt number | R000071500 |
| Scientific Title | A multicenter observational study on the real-world use and effectiveness of IZERVAY for geographic atrophy due to age-related macular degeneration in Japan |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/06 18:42:07 |
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Basic information
Public title
Real-World Evidence Study on the Utilization and Efficacy of IZERVAY (Avacincaptad Pegol Sodium) for Geographic Atrophy Secondary to Age-Related Macular Degeneration in Japan
Acronym
IZERVAY Real-World Evidence Study Japan
Scientific Title
A multicenter observational study on the real-world use and effectiveness of IZERVAY for geographic atrophy due to age-related macular degeneration in Japan
Scientific Title:Acronym
IZERVAY Real-World Evidence Study Japan
Region
| Japan |
Condition
Condition
Geographic Atrophy secondary to Age-Related Macular Degeneration (GA-AMD)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the characteristics of geographic atrophy (GA) lesions before treatment and the rate of change in GA area after treatment with IZERVAY (Avacincaptad Pegol Sodium) in Japanese patients with GA secondary to AMD, in order to clarify the real-world effectiveness, safety, and treatment patterns of IZERVAY in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of change (%) in geographic atrophy (GA) area measured by fundus autofluorescence (FAF) imaging from baseline (initiation of IZERVAY treatment) to each observation time point (6 months, 1 year, 18 months, and 2 years)
Key secondary outcomes
(1)Change in BCVA (decimal and logMAR); (2)Change in OCT findings (CRT, ONL, EZ, RPE, subretinal/intraretinal fluid); (3)Estimation of pre-treatment GA progression rate; (4)Ocular characteristics of non-treated fellow eye; (5)Change in IOP and incidence of IOP elevation; (6)Incidence of new or worsening CNV; (7)Incidence of endophthalmitis; (8)Other adverse events; (9)Actual injection frequency and intervals; (10)Treatment continuation rate (6M/1Y/2Y); (11)Discontinuation rate and reasons; (12)Descriptive statistics of patient backgrounds; (13)GA lesion characteristics at baseline; (14)Physician survey on treatment initiation rationale, treatment burden, and clinical challenges
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients diagnosed with geographic atrophy secondary to age-related macular degeneration; (2) Patients who received intravitreal injections of IZERVAY at a participating institution; (3) Patients aged 20 years or older at the time of initiation of IZERVAY treatment; (4) Patients who provided written informed consent (by themselves or a legally authorized representative) after sufficient explanation
Key exclusion criteria
(1) Patients whose medical records are insufficient for evaluation as judged by the principal investigator or sub-investigator; (2) Patients otherwise deemed ineligible by the principal investigator or sub-investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | shozo |
| Middle name | |
| Last name | sonoda |
Organization
Kagoshima Sonoda Eye Clinic and Plastic Surgery, Myojo-kai Medical Corporation
Division name
Ophthalmologyalmology
Zip code
890-0053
Address
29-4 Chuo-machi, Kagoshima City, Kagoshima 890-0053, Japan
TEL
099-210-5311
sonosho0110@gmail.com
Public contact
Name of contact person
| 1st name | shozo |
| Middle name | |
| Last name | sonoda |
Organization
Kagoshima Sonoda Eye Clinic and Plastic Surgery, Myojo-kai Medical Corporation
Division name
Ophthalmology
Zip code
890-0053
Address
29-4 Chuo-machi, Kagoshima City, Kagoshima 890-0053, Japan
TEL
099-210-5311
Homepage URL
sonosho0110@gmail.com
Sponsor or person
Institute
Kagoshima Sonoda Eye Clinic and Plastic Surgery, Myojo-kai Medical Corporat
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Yamauchi Clinic, Rikei-kai Medical Corporation
Address
1-15-19 Jiyugaoka, Meguro-ku, tokyo
Tel
03-6777-1490
c-irb_ug@neues.co.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 | 09 | 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 | 06 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2031 | 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 multicenter, prospective and retrospective mixed observational study. Patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who received intravitreal injections of IZERVAY (Avacincaptad Pegol Sodium) at participating institutions are enrolled. The retrospective observation period covers up to 2 years prior to IZERVAY initiation; the prospective observation period covers at least 1 year (up to 2 years) after IZERVAY initiation. No control group is set (non-comparative, descriptive study). No randomization is performed. Sampling is by consecutive convenience sampling: all eligible patients at each site are enrolled.
Management information
Registered date
| 2026 | Year | 08 | Month | 06 | Day |
Last modified on
| 2026 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071500
