Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062498) titled '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' on Sept. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Kagoshima Sonoda Eye Clinic and Plastic Surgery, Myojo-kai Medical Corporat
Condition:
Condition - Geographic Atrophy secondary to Age-Related Macular Degeneration (GA-AMD)
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Eligibility:
Age-lower limit - 20
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 Size - 100
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071500
Disclaimer: Curated by HT Syndication.