RecruitingPhase 4NCT07367282

Evaluate the Efficacy of Faricimab in Patients With Neovascular Age-related Macular Degeneration

A Phase IV, Prospective, Open-label, Single-arm Clinical Trial to Evaluate the Efficacy of Faricimab and Biomarker Assessment in Patients With Neovascular Age-related Macular Degeneration


Sponsor

Junyeop Lee

Enrollment

64 participants

Start Date

Jun 29, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

If the subject who has nAMD voluntarily agrees to participate in this clinical study by signing the informed consent form, screening assessments will be conducted within 4 weeks prior to the first dose of the investigational drug. During the screening visit, the eligibility of the subject will be assessed and one study eye will be selected. If both eyes are eligible, the eye with the worst best-corrected visual acuity (BCVA) at screening will be chosen. However, if the investigator determines that the other eye requires more urgent treatment for clinical reasons, that eye may be selected as the study eye. After screening assessments and evaluation based on inclusion/exclusion criteria, eligible subjects will be enrolled. Vabysmo® 6 mg (0.05 mL) will be administered via intravitreal injection every 4 weeks (monthly) for a total of 4 doses during the initial loading period. After the loading dose, patients will undergo disease activity assessment based on imaging and visual acuity (VA) outcomes followed by the IP administration at Week 20. The treatment interval will be determined based on disease activity assessed at Week 20, depending on the results, the subsequent administration may be scheduled at Week 28 or Week 32, at the investigator's discretion. Thereafter, the dosing interval may be further adjusted in 4-week increments, either extended or shortened, according to imaging and visual outcomes. Throughout the clinical study, patients will need to visit the study site at least 10 times, including the screening visit. The number of intravitreal injections administered will be 4 doses during the initial loading period and up to 5 doses during the treat-and-extend (T\&E) period (Weeks 20, 28, 36, 44, 52). Thus, the total number of injections during the study will range from a minimum of 7 to a maximum of 9 injections. If the non-study eye also has nAMD, treatment with a locally approved therapy may be administered outside the scope of this study.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Faricimab Injection [Vabysmo] for people with macular degeneration. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFaricimab Injection [Vabysmo]

Faricimab Injection 6mg 0.05 cc


Locations(5)

Seoul National University Bundang Hospital

Seongnam, South Korea

Asan Medical Center

Seoul, South Korea

Kyung Hee University Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul St. Mary's Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT07367282


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